Companies Developing COVID-19 Therapies

Bausch Health Initiates VIRAZOLE® (Ribavirin for Inhalation Solution, USP) Clinical Study in Patients with COVID-19 - a clinical trial program in Canada evaluating an investigational use of VIRAZOLE® (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19. Because ribavirin is a synthetic nucleoside that works to stop viral replication, VIRAZOLE may be effective in reducing the severity of COVID-19 infection. VIRAZOLE is currently approved in several countries around the world, including the United States and Canada, for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV).

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

BioCryst Begins Clinical Trial with Galidesivir for Treatment of Patients with COVID-19 - The company has opened enrollment into a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. For more information on the trial, see A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever

Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

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. 

CanSinoBIO’s Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China - The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform. Results from preclinical animal studies of “Ad5-nCoV” show that the vaccine candidate can induce strong immune response in animal models. The preclinical animal safety studies demonstrated a good safety profile.

A Phase I Clinical Trial in 18-60 Adults

Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy - Celularity Inc., a clinical-stage company developing allogeneic cellular therapies from human placentas, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86 patients with COVID-19. 

Other companies mentioned: Sorrento Therapeutics, United Therapeutics/Lung Biotechnology

MediciNova Announces Plans to Initiate a Clinical Trial of MN-166 (ibudilast) for COVID-19 Acute Respiratory Distress Syndrome (ARDS) - MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. The lead Principal Investigator (PI) for this trial is Dr. Geoffrey Chupp, Professor of Medicine (Pulmonology), Director of the Yale Center for Asthma and Airway Disease and Director of the Pulmonary Function Laboratory at Yale-New Haven Hospital.  

MediciNova Announces Plans to Develop MN-166 (ibudilast) for Severe Pneumonia and Acute Respiratory Distress Syndrome (ARDS) - MediciNova’s decision to pursue development of this indication was based on positive results of a recent preclinical study in an animal model of ARDS (Med Sci Monit, 2020; 26: e922281). Results of this preclinical study showed that ibudilast treatment reversed histological changes observed in the ARDS mouse model including inflammation, hemor­rhage, alveolar congestion, and alveolar wall edema.

Single-Patient EA Policies/Criteria

Currently, MediciNova is not accepting requests from patients or their advocates (including treating physicians) under the Expanded Access/Compassionate Use Program because of its focus on planned Phase 3 trials to evaluate MN-166 (ibudilast). 

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.

Read more about developing therapeutics and vaccines for coronaviruses 

NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells.  NIAID conducted a phase 1 clinical trial of  SAB-301, an experimental MERS treatment developed from cattle that make human antibodies.  This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated.  Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.

NIH clinical trial of investigational vaccine for COVID-19 begins

Disease/Category-Specific EA Policies/Criteria

Developing Therapeutics and Vaccines for Coronaviruses

https://www.niaid.nih.gov/diseases-conditions/coronaviruses-therapeutics-vaccines

NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells.  NIAID conducted a phase 1 clinical trial of  SAB-301, an experimental MERS treatment developed from cattle that make human antibodies.  This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated.  Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.

NIH clinical trial of investigational vaccine for COVID-19 begins

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

Novavax Awarded Funding from CEPI for COVID-19 Vaccine Development - Novavax has produced and is currently assessing multiple recombinant nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase1 clinical testing is expected in late spring of 2020. Novavax’ COVID-19 vaccine candidates were created with its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax recently entered into an agreement with Emergent BioSolutions, Inc. (Emergent) to provide contract development and manufacturing services, supplying Novavax with vaccine product for preclinical testing and for use in its Phase 1 clinical trial. 

Ridgeback Biotherapeutics Announces MHRA Clearance to Begin Human Testing of EIDD-2801 in the UK for COVID-19 and the Start of Phase 1 - This action by the MHRA allowed Ridgeback to commence Phase 1 in the UK on Friday April 10^th. EIDD-2801 is a direct acting anti-viral nucleoside analogue.  Essentially, EIDD-2801 tricks RNA viruses into including the wrong building blocks as it tries to reproduce itself.  This leads to dramatically reduced levels of virus in animals infected with a wide variety of RNA viruses when treated with EIDD-2801.  EIDD-2801 has been shown to treat MERS and SARS (two severe coronavirus infections) in animals when given after an infection has been established.  When given prophylactically EIDD-2801 is able to prevent significant manifestations of disease in animals challenged with MERS and SARS.    

FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19 - The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics.  This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the United States. EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19, and has shown potent activity against SARS-CoV and MERS-CoV in animal models of infection. In addition to coronaviruses, EIDD-2801 has broad spectrum activity against a number of diseases of public health concern, including influenza, chikungunya, Ebola, and equine encephalitis (VEE and EEE). The antiviral is orally available and, in addition to COVID-19, is being developed for the treatment of seasonal and pandemic influenza under a contract awarded to Emory Institute for Drug Development by the National Institute of Allergy and Infectious Diseases (NIAID) and for Venezuelan and Eastern equine encephalitis virus (VEEV and EEEV) by the Defense Threat Reduction Agency (DTRA). 

Disease/Category-Specific EA Policies/Criteria

mAb114 is currently under study in the Democratic Republic of the Congo through an Expanded Access Protocol administered as part of the Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola virus disease (MEURI).

Roivant Announces Development of Anti-GM-CSF Monoclonal Antibody to Prevent and Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19

• Gimsilumab is a monoclonal antibody that targets GM-CSF, a pro-inflammatory cytokine found to be up-regulated in COVID-19 patients
• Emerging clinical evidence in COVID-19 patients suggests that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS
• ARDS is a serious complication of COVID-19 which necessitates hospitalization and mechanical ventilation or other life support measures
• A Phase 1 study of gimsilumab conducted by Roivant completed dosing last month following extensive non-clinical research; gimsilumab treatment has been associated with a favorable safety and tolerability profile to date