COVID-19 Drug Research Roundup
Below is a roundup of research activity on COVID-19 vaccines and treatments. The current U.S. trials are operating on a fast enrollment pace, according to WCG Clinical’s Knowledge Base, with 30 percent expected to be fully enrolled within three months. More than 6,500 patients are needed to fill open slots in the 56 active COVID-19 industry-sponsored trials in the U.S. In the past six weeks, the U.S. added two new trials, up from 54. To see last week’s column, click here.
The European Medicines Agency assembled a COVID-19 task force to coordinate vaccine in the EU in response to the crisis. The independent expert group will identify promising candidates for the EMA’s Committee for Medicinal Products for Human Use (CHMP) to review, and it will support developers of promising drugs in their clinical trials.
China-based CanSino Bio’s trial of its vaccine candidate Ad5-nCoV has entered phase 2, making it the frontrunner among vaccines thus far. The double-blind, placebo-controlled study in 500 healthy patients will be conducted with assistance from the Academy of Military Medical Sciences’ Institute of Biotechnology.
GlaxoSmithKline and Sanofi have teamed up to develop a coronavirus vaccine that includes an adjuvant to boost a patient’s immune response. The drugmakers said they plan to begin phase 1 clinical trials in the second half of 2020 and hope to have a vaccine available by the second half of 2021.
Moderna’s phase 1 trial of its vaccine candidate, mRNA-1273, has begun enrolling participants at the highest dose.
Immunomic Therapeutics has begun collaborating with PharmaJet and EpiVax to develop a nucleic acid COVID-19 vaccine candidate. The three companies are looking to develop a scalable, heat-stable vaccine that can be administered using PharmaJet’s needle-free injection system.
As it’s doing with vaccines, the European Medicines Agency assembled a COVID-19 task force to coordinate therapeutic development in the EU in response to the crisis. The independent expert group will identify promising candidates for the EMA’s Committee for Medicinal Products for Human Use (CHMP) to review, and it will support developers of promising drugs in their clinical trials.
BioCryst has opened enrollment for its clinical trial of the antiviral drug galidesivir in patients with COVID-19. The Brazilian trial is being funded by the NIH’s National Institute of Allergy and Infectious Diseases and will begin with 24 hospitalized moderate-to-severe coronavirus patients.
CalciMedica’s trial of CM4620-IE, a small molecule CRAC channel inhibitor, has been granted permission by the FDA to enter phase 2. The study, which involves patients with severe COVID-19 pneumonia, is expected to begin within the next week at Detroit’s Henry Ford Hospital.
Eli Lilly announced that it will begin a trial this month of the rheumatoid arthritis JAK inhibitor baricitinib to see how it fares in treating COVID-19. The company said it expects to have results from the study in the next two months.
Bausch Health has begun a clinical trial program in Canada studying the antiviral Virazole (ribavirin) alongside standard of care for hospitalized adults with respiratory distress from COVID-19. The clinical study is expected to begin within the next few weeks. The company said it is also in talks with the FDA about conducting U.S. trials.
Fujifilm has initiated a phase 2 clinical trial in the U.S. to evaluate its influenza antiviral Avigan (favipiravir) in COVID-19 patients. It will enroll approximately 50 patients in a collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital and the University of Massachusetts Medical School.
AstraZeneca has begun conducting a phase 2 trial of its BTK inhibitor Calquence (acalabrutinib) for treating exaggerated immune response in COVID-19 patients. The trial will evaluate the safety and efficacy of adding Calquence, a drug approved for mantle cell lymphoma and chronic lymphocytic leukemia, to best supportive care to reduce mortality and the need for assisted ventilation.
BioSig Technologies’ subsidiary ViralClear Pharmaceuticals will begin a phase 2 trial of Vicromax (merimepodib) at the Mayo Clinic as a treatment for COVID-19. Data from the randomized, placebo-controlled study is expected within three months.
Octapharma said it is supporting a San Diego, Calif.-based trial of intravenous immunoglobulin in treating the most critical COVID-19 patients. The trial is expected to enroll 20 patients hospitalized with COVID-19 that require significant oxygen but aren’t on mechanical ventilation.
Roivant has dosed the first patient in its study of the monoclonal antibody gimsilumab at Temple University Hospital in Philadelphia. The trial involves COVID-19 patients with lung injury or acute respiratory distress syndrome. The company said it will soon begin dosing at other trial sites, including New York City’s Mount Sinai Hospital.