Companies Developing COVID-19 Therapies

We have initiated a Phase 2 study of IMBRUVICA (ibrutinib) in patients with COVID-19 infection. The goal of this study is to determine whether IMBRUVICA is able to improve patient outcomes by diminishing the immune response known as the cytokine storm that contributes to the morbidity and mortality in COVID-19.  See: Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With CoronaVirus Induced Disease 2019 (COVID-19) and Pulmonary Distress

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO)

https://clinicaltrials.gov/ct2/show/NCT04330690?term=abbvie&recrs=acdfk&cond=COVID&draw=2&rank=1

AbbVie Partnering with Global Authorities to Determine Efficacy of HIV Drug in Treating COVID-19

Unconfirmed media reports from China claim Kaletra/Aluvia (lopinavir/ritonavir) is effective in COVID-19 treatment.
- AbbVie does not have access to Chinese clinical information and therefore cannot confirm its accuracy
- AbbVie donated Aluvia to the Chinese government for experimental use against COVID-19
- AbbVie is working with global health authorities to determine the efficacy and safety of lopinavir/ritonavir against COVID-19

Alexion Announces Plans to Initiate Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19 - Alexion announced plans to initiate a global Phase 3 study to investigate ULTOMIRIS® (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS). The study is expected to enroll approximately 270 patients across countries with high numbers of diagnosed cases, and will evaluate the impact of ULTOMIRIS, a biologic medicine, on survival, duration of mechanical ventilation, and hospital stay compared to best supportive care. 

Alexion Statement on SOLIRIS® (eculizumab) and COVID-19 - Alexion has provided SOLIRIS as an experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia. Requests are assessed on a case-by-case basis, with priority given to those with clinical trial experience and the oversight of a physician who has extensive experience using SOLIRIS.

Emergency Treatment for COVID-19 https://alexion.com/our-commitment/global-access-to-medicines

For more information, contact us at covid.requests@alexion.com.

Disease/Category-Specific EA Policies/Criteria

Emergency Treatment for COVID-19 https://alexion.com/our-commitment/global-access-to-medicines

Alexion has provided SOLIRIS as an experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia. Requests are assessed on a case-by-case basis, with priority given to those with clinical trial experience and the oversight of a physician who has extensive experience using SOLIRIS.

For more information, contact us at covid.requests@alexion.com.

Eculizumab (Soliris) in Covid-19 Infected Patients  (Expanded Access Study)

ULTOMIRIS^® (ravulizumab-cwvz) - the first and only long-acting C5 complement inhibitor

Algernon Announces 50% Enrollment in Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 - Algernon has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The Company is now projecting that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020. The multinational Phase 2b/3 human trial for COVID-19 is entitled, "A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease." The trial has begun as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.

Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial - NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils. The trial will begin as a Phase 2b study and after an interim analysis is performed on the first 100 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial. With positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3. 

Read more here: https://algernonpharmaceuticals.com/covid-19-global-treatment-initiatives/ 

APEIRON’s respiratory drug product to start pilot clinical trial to treat coronavirus disease COVID-19 in China. APEIRON Biologics AG today announced that it has received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2), and has the potential to block the infection of cells by the novel SARS-CoV-2 virus (COVID-19), and reduce lung injury. The Phase II trial aims to treat 200 severely infected COVID-19 patients, and the first patients are expected to be dosed shortly.

Press release

Applied Therapeutics Announces IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients - A COVID-19 IND has been opened with the FDA for AT-001, a novel potent Aldose Reductase inhibitor in global Phase 3 development for Diabetic Cardiomyopathy. Multiple AT-001 investigator-initiated trials are now underway to address acute lung inflammation and cardiomyopathy in critical COVID-19 patients. Several New York City hospitals have initiated Emergency Investigational Drug applications for AT-001 use in critical COVID-19 patients.  AT-001 is currently being accessed in these New York City hospitals via “Named Patient” Emergency INDs or Investigator-Initiated Trials, depending on the patient circumstance and hospital institution.  Institutions that have initiated trials include Mount Sinai, NYU, and Columbia. To date, all patients treated under Emergency INDs have demonstrated improvement in cardiopulmonary function.  Additional data is being gathered through studies on the effect of AT-001 therapy in critical COVID-19 patients.

See also: Cardiovascular Effects of COVID-19

Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients - The data from this small-sample clinical study showed that danoprevir combined with ritonavir is safe and well tolerated in all patients. After 4 to 12-day treatment of danoprevir combined with ritonavir, all eleven moderate COVID-19 patients enrolled, two naive and nine experienced, were discharged from the hospital as they met all four conditions as follows: (1) normal body temperature for at least 3 days; (2) significantly improved respiratory symptoms; (3) lung imaging shows obvious absorption and recovery of acute exudative lesion; and (4) two consecutive RT-PCR negative tests of SARS-CoV-2 nucleotide acid (respiratory track sampling with interval at least one day).

Progress of the Small Sample Clinical Trial of Ganovo® and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia

MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

We are running a Pivotal Phase 2/3 clinical trial evaluating MultiStem cell therapy in COVID-19 induced ARDS patients. This trial is a multicenter study with an open-label, single active treatment arm for cohort 1 followed by a double-blind, randomized, placebo-controlled Phase 2/3 portion. The primary objectives of the MACOVIA study are to evaluate the safety and efficacy of MultiStem therapy as a treatment for subjects with moderate to severe ARDS due to COVID-19.

For more info: https://www.athersys.com/clinical-trials/ards/default.aspx

Biomarck's BIO-11006 has two active INDs, including one is for respiratory disease. We have commenced enrollment in Phase 2 controlled clinical studies in Acute Respiratory Distress Syndrome (ARDS). See below for more information.

Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS

A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer

Disease/Category-Specific EA Policies/Criteria

biomarck pharmaceuticals intends to support children with difficult to treat cancers such as Rhabdomyosarcoma and Neuroblastoma. This may be done by a compassionate use program under the Investigator IND of the treating hospital. This effort will be done in support of the concepts of non-profit organizations such as the Miami based Live Like Bella Foundation (Learn More) which supports children with cancer, their families and research into childhood cancer.

BIO-11006 is an investigational peptide medication delivered by nebulizer which has shown activity in the laboratory and in animal studies in certain types of cancer. It has been granted FDA acceptance to begin studies in adult lung cancer. BIO-11006 has been given to over 200 patients with COPD (chronic bronchitis and emphysema) and been shown to have a good safety profile at the recommended dose. It has not been given to children or cancer patients in controlled clinical studies.

Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine - The collaboration aims to accelerate development of BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162, which is expected to enter clinical testing by the end of April 2020. 

FDA Grants CalciMedica Permission to Begin Dosing CM4620-IE in Patients with Severe COVID-19 Pneumonia under a Newly Opened IND 

• Regions Hospital in St. Paul, Minnesota has begun a Phase 2 clinical study of CM4620-IE in patients with severe COVID-19 pneumonia who develop hypoxemic respiratory failure and are at risk for progression to acute respiratory distress syndrome, and Henry Ford Hospital in Detroit is expected to begin shortly after

• CM4620-IE is a potent and selective small molecule that may prevent pulmonary endothelial damage and lessen the cytokine storm in COVID-19

• CM4620-IE has demonstrated clinical safety and potential efficacy in patients with hypoxemia secondary to systemic inflammatory response syndrome in the setting of acute pancreatitis

• The open-label Phase 2a clinical trial aims to enroll 60 patients with severe COVID-19 pneumonia and a PaO2/FiO2≤300, patients who are risk to progress to mechanical ventilation. Forty patients will be assigned to CM4620-IE plus standard of care and 20 assigned to standard of care alone. The therapy will be delivered intravenously with the aim of keeping COVID-19 patients with severe pneumonia, whose breathing is rapidly declining, from “crashing” and needing ventilators by decreasing inflammation in the lungs. 

Cerecor Announces FDA Clearance of IND for CERC-002 in COVID-19 Induced ARDS - Cerecor will proceed with a proof-of-concept clinical trial of its anti-LIGHT monoclonal antibody CERC-002 in patients with COVID-19 cytokine storm induced Acute Respiratory Distress Syndrome (ARDS). The study will assess the efficacy and safety of CERC-002. The first patient is expected to enroll in June and top-line data are expected in the fourth quarter of 2020. The randomized, multi-center, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. 

CytoDyn’s Phase 2 Study of Leronlimab for Mild-to-Moderate COVID-19 Selected for Oral Presentation at the Special isirv-AVG Virtual Conference on ‘Therapeutics for COVID-19’ -  An oral presentation was given at the Special isirv-Antiviral Group Conference on ‘Therapeutics for COVID-19.’ Additional details can be found on the conference web site here. 

see also: https://www.clinicaltrials.gov/ct2/show/NCT04347239?term=leronlimab&cond=Covid19&draw=2&rank=2 for late onset intervention therapies 

Novant Health Initiates Phase 2 COVID-19 Trial with CytoDyn’s Leronlimab - Novant Health is initiating patient enrollment in CytoDyn’s Phase 2 randomized clinical trial for COVID-19 patients with mild-to-moderate indications.  Novant Health is the first site in the southeastern United States to initiate this Phase 2 trial and the second clinical trial site in the nation.

Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients - Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation

CytoDyn Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication – Primary End Point Announcement Is Next - CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

Available Therapies via Single-Patient EA

A Compassionate Use Study of Leronlimab in Breast Cancer

Eiger BioPharmaceuticals Announces First COVID-19 Patients Dosed with Peginterferon Lambda - Approximately 120 patients with mild COVID-19 at the Stanford University School of Medicine will be randomized 1:1 to a single subcutaneous dose of Lambda or normal saline placebo to evaluate the efficacy of Lambda in reducing the duration of viral shedding of SARS-CoV-2 virus and in reducing duration of symptoms and hospitalization in patients with mild COVID-19.  Patients will be followed for 28 days.

Available Therapies via Single-Patient EA

• Lonafarnib
• Pegylated Interferon Lambda
• Avexitide

Disease/Category-Specific EA Policies/Criteria

The Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathy Managed Access Program

Eiger BioPharmaceuticals, the distributor of the drug lonafarnib, is sponsoring a Managed Access Program (MAP) for eligible patients with Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) or a Progeroid Laminopathy (PL).  The protocol governing this program can be viewed at ClinicalTrials.gov. The MAP study number is NCT03895528.  Clinigen is the administrator of the lonafarnib MAP for HGPS and PL.

Patients or family members desiring more information about this program should speak to their doctors  or contact The Progeria Research Foundation at 978-535-2594 or e-mail info@progeriaresearch.org.  Patients and family members should not contact Clinigen.  Clinigen is only authorized to speak with doctors.

For treating doctors with questions about the MAP, please contact Clinigen’s Medicine Access Team at +44 (0) 1932 824123 or email medicineaccess@clinigengroup.com.  The doctor may also e-mail Eiger at ProgeriaMA@eigerbio.com or Eigeraccess@eigerbio.com.

Lilly Announces Proof of Concept Data for Neutralizing Antibody LY-CoV555 in the COVID-19 Outpatient Setting - Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).

see: https://clinicaltrials.gov/ct2/results?cond=&term=nct04497987&cntry=&state=&city=&dist= 

Lilly's Neutralizing Antibodies and COVID-19 Fact Sheet 

Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial - Lilly announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.

Eli Lilly and Company announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study Olumiant (baricitinib) as an arm in NIAID's Adaptive COVID-19 Treatment Trial. Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT^®, is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Given the inflammatory cascade seen in COVID-19, baricitinib's anti-inflammatory activity has been hypothesized to have a potential beneficial effect in COVID-19 and warrants further study in patients with this infection. https://investor.lilly.com/news-releases/news-release-details/lilly-begins-clinical-testing-therapies-covid-19

see also: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=baricitinib&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

AbCellera and Lilly to Co-develop Antibody Therapies for the Treatment of COVID-19 - AbCellera and Lilly will select from 500+ unique antibodies isolated from one of the first U.S. patients who recovered from COVID-19 to create antibody therapeutics for treatment and prevention of COVID-19

Eusa Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy announce initiation of an observational case-control study of Siltuximab in patients with COVID-19 who have developed serious respiratory complications.

For more information: https://www.eusapharma.com/news/eusa-pharma-and-the-papa-giovanni-xxiii-hospital/

COVID-19 Resource Page

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

Expanded Access Remdesivir (RDV; GS-5734™) - for DOD/military personnel only

Emergency Access to Remdesivir Outside of Clinical Trials

Remdesivir Clinical Trials

An Open Letter from our Chairman and CEO (March 28, 2020)

An Update on COVID-19 from our Chairman & CEO (April 4, 2020)

"Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations." 

Disease/Category-Specific EA Policies/Criteria

Emergency Access to Remdesivir Outside of Clinical Trials

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

Expanded Access Remdesivir (RDV; GS-5734™) - for DOD/military personnel only

Remdesivir Clinical Trials

I-Mab Announces IND Clearance from FDA for TJM2 to Treat Cytokine Release Syndrome (CRS) Associated with Severe Coronavirus Disease 19 (COVID-19) - TJM2, also known as TJ003234, is an I-Mab-discovered neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation. The proposed clinical trial is a multi-center, randomized, double-blind, placebo-controlled, three-arm study to evaluate the safety, tolerability and efficacy of TJM2 in reducing the severity of complications as well as levels of multiple cytokines in patients with severe COVID-19.

InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive Human Data with InflaRx’s anti-C5a Technology - Announces the enrollment of the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, the company´s monoclonal anti-C5a antibody, in patients with severe COVID-19-induced pneumonia. The company has received initial positive human data from two initial patients suffering from COVID-19-induced severe pneumonia who were treated with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1 cell line, in China. Data from the two patients are part of a larger investigation on the role of complement activation in COVID-19 which have been made publicly available through a pre-print server and have not been independently validated by InflaRx.

We have been conducting an exploratory translational study, called EXPLORE COVID-19, in collaboration with La Timone, North and Laveran hospitals and the Marseille Immunopôle/AP-HM immunoprofiling laboratory at La Timone hospital, Marseille, to analyze immune cells in COVID-19 patients at different stages of the disease. Researchers reported an increase in soluble C5a, a highly inflammatory peptide of the complement cascade, which was elevated based on the severity of the disease in patients with pneumonia and acute respiratory distress syndrome (ARDS). 

On April 28, 2020, we announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of our anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia. The primary objective of this investigator-sponsored trial, named FORCE (FOR COVID-19 Elimination), is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by ARDS.  

For more info: First patient dosed in avdoralimab Phase II clinical trial in COVID-19 patients with severe pneumonia

and MARSEILLE-BASED TASKFORCE ANNOUNCES THE RESULTS OF EXPLORE COVID-19 TRANSLATIONAL STUDY

https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=%22Innate+Pharma%22&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Karyopharm to Evaluate Low Dose Selinexor as a Potential Treatment for Hospitalized Patients with COVID-19 - Will initiate a global randomized clinical trial for low dose oral selinexor in hospitalized patients with severe COVID-19. Selinexor, marketed as XPOVIO^®, is currently approved at higher doses by the Food and Drug Administration (FDA) as a treatment for patients with relapsed or refractory multiple myeloma. Selinexor is an oral, selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1. The proposed clinical trial to treat hospitalized patients with COVID-19 would be the first study of an XPO1 inhibitor in patients with severe viral infections.

Karyopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-19 - First patient enrolled in a randomized Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19. This global study is expected to enroll approximately 230 patients at clinical sites in the U.S., Europe, and Israel. 

Available Therapies via Single-Patient EA

Patients with the following conditions who meet certain inclusion/exclusion criteria may be provided access to selinexor:

• Patients with relapsed or refractory multiple myeloma
• Patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL)
• Patients with advanced sarcoma
• Patient with other diseases in which selinexor has been studied in clinical trials will be assessed on a case-by-case basis

Laurent Pharmaceuticals Joins Battle Against COVID-19 - The company is planning to test its lead drug LAU-7b in patients with COVID-19 disease, as part of a Phase 2 clinical trial. LAU-7b is a novel once-a-day oral form of fenretinide, an investigational drug under development by Laurent Pharmaceuticals for its ability to help control inflammation in the lungs.  Laurent is working closely with regulatory authorities in Canada and United States, planning to initiate a randomized, placebo-controlled Phase II clinical study, within a month. The study will involve approximatively 200 patients diagnosed with COVID-19 and at risk to develop lung complications, for a treatment duration of 14 days.

Mallinckrodt Supports Investigator-Initiated Study at Massachusetts General Hospital to Assess Effectiveness of Inhaled Nitric Oxide in Patients with Severe Acute Respiratory Distress Syndrome Due to COVID-19 - an investigator-initiated clinical study at Massachusetts General Hospital evaluating the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19. Mallinckrodt's support to Massachusetts General Hospital includes providing funding as well as INOmax^® (nitric oxide) gas, for inhalation, to facilitate the study. The study is titled "Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19." See: Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19

Mallinckrodt and Novoteris Receive Clearance from Health Canada to Start Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications -  Mallinckrodt plc and Novoteris, LLC announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox^®, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy's safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days.

US NIH Trials Network to Conduct COVID-19 Phase 2/3 Trial - Mesoblast Limited has announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials.

Moderna Confirms Discussions with the Ministry of Health, Labour and Welfare to Supply Japan with 40 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna confirmed that the Company is engaged in discussions with the Ministry of Health, Labour and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the public as soon as possible. Under the terms of this arrangement, the vaccine would be supplied by Moderna, Inc. and distributed in Japan by Takeda Pharmaceutical Co., Ltd. (NYSE: TAK) beginning in the first half of 2021, if the vaccine receives regulatory approval. Kato Katsunobu, Minister of MHLW, announced the discussions in a meeting with media today in Japan.

Moderna to Present New Interim Clinical Data About mRNA Vaccine Against COVID-19 (mRNA-1273) at Advisory Committee on Immunization Practices (ACIP) Meeting - Moderna announced its presentation at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) August Meeting. The live presentation can be viewed online here.This presentation includes new interim safety and immunogenicity data from the cohorts of older adults in the NIH-led Phase 1 study of mRNA-1273, Moderna’s vaccine candidate against COVID-19. The ACIP presentation slides will be available under “Events and Presentations” in the Investors section of the Moderna website.

Moderna Confirms Advanced Discussions with European Commission to Supply Europe with 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna has concluded advanced exploratory talks with the European Commission to supply 80 million doses of mRNA-1273 as part of the European Commission’s goal to secure early access to safe and effective COVID-19 vaccines for Europe.The potential purchase agreement with the European Commission of 80 million doses provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The discussions are intended to ensure that Member States have access to Moderna’s vaccine. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. 

Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - The U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, this announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. 

Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus - Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.

see also: https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19 - This page summarizes key milestones  to advance mRNA-1273, Moderna's vaccine candidate against the novel coronavirus.

Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine® in Patients with COVID-19 Associated Respiratory Illness. The study at University Hospital Ghent in Belgium will evaluate the effect of Leukine on lung function and patient outcomes. For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator.

PharmaMar has submitted a Phase II clinical trial of Aplidin® (plitidepsin) for the treatment of COVID-19 to the Spanish Medicines Agency - The objective of the trial is to evaluate the efficacy and safety of plitidepsin as a treatment for COVID-19 (SARS-CoV-2) in hospitalized patients. Plitidepsin, which is approved in Australia for the treatment of multiple myeloma, has also demonstrated efficacy as an antiviral in in vitro studies conducted at the Spanish CSIC's National Biotechnology Center against the human coronavirus HCoV-229E, and previously against other types of virus at the Carlos III Health Institute.

PharmaMar reports positive results for Aplidin® against coronavirus HCoV-229E

Available Therapies via Single-Patient EA

There is an Expanded Access Program (EAP) for lurbinectedin to treat patients in the United States (U.S.) with relapsed Small Cell Lung Cancer (SCLC), who are unable to enter clinical trials and there are no appropriate alternative treatments.

Healthcare professionals wishing to request access to lurbinectedin under the EAP or who would like to find out more should do so by emailing Lurbinectedin.EAP@Bionical-Emas.com.

See also A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

Opaganib - COVID-19 - RedHill is working to develop opaganib (Yeliva, ACB294640) for COVID-19. Opaganib has a unique mechanism of action, with both anti-inflammatory and anti-viral activity, targeting a critical host factor, which minimizes the potential development of resistance due to viral mutations. RedHill is advancing a development program evaluating opaganib as a therapy for patients with severe COVID-19 infection, which includes two ongoing clinical studies:

• A global randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study (NCT04467840)
   
• A U.S. randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618)

RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico - The global Phase 2/3 study with opaganib is set to enroll up to 270 patients with severe COVID-19 across 40 clinical site. The global Phase 2/3 study has been approved in Mexico, the UK and Russia and is also under review in Italy, Brazil and additional countries. Enrollment in a parallel U.S. Phase 2 study in patients with severe COVID-19 is approximately 50% complete and is expected to be completed this month. Potential submission of global emergency use applications planned as early as Q4/2020.

RedHill Biopharma Announces Approval of Compassionate Use of Opaganib for COVID-19 in Italy  

RedHill Announces First COVID-19 Patient Treated with Opaganib in Israel Under Compassionate Use 

Available Therapies via Single-Patient EA

COVID-19 - Yeliva (opaganib)

Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

RECOVERY COVID-19 phase 3 trial to evaluate REGENERON'S REGN-COV2 investigational antibody cocktail in the UK - Regeneron and the University of Oxford announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.

REGENERON Announces Start of REGN-COV2 Phase 3 Covid-19 Prevention Trial in Collaboration With National Institute Of Allergy And Infectious Diseases (NIAID) - A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.

Developing REGN-COV2 (see: https://www.regeneron.com/covid19) - REGN-COV2 is a novel anti-viral antibody cocktail that is being studied for its potential both to treat people with COVID-19 and to prevent SARS-CoV-2 infection. REGN-COV2 is currently being studied in four late-stage clinical trials: two Phase 2/3 trials for the treatment of hospitalized and non-hospitalized (“ambulatory”) COVID-19 patients, the open-label, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient (such as the patient’s housemate). The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The safety of REGN-COV2 is also being evaluated in a Phase 1 healthy volunteer study.

If you are interested in participating in one of Regeneron's COVID-19 clinical trials, please complete a brief online screener at ClinLife.com/COVID to see if you qualify.

Based on recent clinical data from studies in China with another IL-6 inhibitor, we believe there is a potential role for Kevzara^® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with our collaborators at Sanofi, we are conducting controlled clinical studies to evaluate Kevzara in this setting. The use of Kevzara to treat people with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

For more info, go to:  Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

See also: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=sarilumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

See also Sanofi in company directory.

Frequently requested information about Roche medicines and COVID-19: https://medinfo.roche.com/

Includes fact sheets on:

Actemra/RoActemra (tocilizumab) - Download

Ocrevus (ocrelizumab) - Download

Tamiflu (oseltamivir) - Download

Roche statement on coronavirus (Update 19.03.2020)

Other companies mentioned/involved:  Chugai Pharmaceuticals; Zhejiang Hisun Pharmaceuticals

Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Single-Patient EA Policies/Criteria

https://www.roche.com/dam/jcr:035f3847-505e-484c-b5f6-f666790791de/24_Position%20on%20Pre%20Approval%20Access%20on%20Investigational%20Medicinal%20Products_reviewed_March%202019.pdf

First patient outside U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19

• Phase 2/3 trial initiated in Italy, Spain, Germany, France, Canada and Russia and is enrolling patients immediately
• Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection
• Sanofi is leading trials outside the U.S., while Regeneron is leading U.S. trials

For more info, go to:  Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

See also: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=sarilumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

See also Regeneron in the company directory

Sanofi and Translate Bio collaborate to develop novel mRNA vaccine candidate against COVID-19

On the 18th March Synairgen announced that it has received expedited approvals from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of SNG001 in COVID-19 patients. Synairgen is developing a formulation of IFN-beta, called SNG001, for direct delivery to the lungs via nebulisation, to treat and/or prevent LRT illness caused by respiratory viruses. Synairgen’s Phase II trial in COVID-19 patients, called SG016 (EudraCT: 2020-001023-14), is a double-blind, placebo-controlled trial. Initially, the pilot phase of the study involving 100 COVID-19 patients, is taking place across a number of NHS trusts in the United Kingdom.

https://www.synairgen.com/covid-19/

Commencement of dosing in COVID-19 trial

Synairgen to start trial of SNG001 in COVID-19 imminently

Disease/Category-Specific EA Policies/Criteria

On the 18^th March Synairgen announced its plans to initiate a pilot clinical trial of SNG001 in COVID-19 patients. The trial will provide data on the efficacy of inhaled interferon beta in the treatment of ambulatory and hospitalised patients infected with SARS-CoV-2. Since the announcement, we have received a number of requests for SNG001 supplies to treat individuals outside the trial. As SNG001 is an experimental drug, untested as to safety and efficacy in this patient group, we regret that we are unable to fulfil any such request at this time. Synairgen’s team is working very hard to establish these measures in a well-controlled environment as quickly as possible. https://www.synairgen.com/