COVID-19 Drug Research Roundup
GlaxoSmithKline and Vir Biotechnology have started to recruit participants for phase 3 trials investigating the efficacy and safety of VIR-7831, a monoclonal antibody, for the treatment of COVID-19 in high-risk patients. The trials follow positive safety and tolerability data from a phase 2 trial and will be conducted in North America, South America and Europe. Approximately 1,300 nonhospitalized patients will be randomized to receive either a single intravenous infusion of the COVID-19 therapy candidate or placebo. Endpoints include hospitalization or death within 29 days of treatment. The companies have stated they will have interim results available by the end of 2020, and complete results will be available in the first quarter of next year.
Shanghai Fosun Pharmaceutical Group’s experimental antibody treatment for COVID-19, developed by Fosun unit Hengenix Biotech, has been approved for early human testing in the U.S. The company has invested approximately $2.2 million into the development of the antibody therapy, termed HLX70, as of August.
Hot on the heels of positive trial data, Eli Lilly submitted an Emergency Use Authorization (EUA) request for monoclonal antibody, LY-CoV555, for the treatment of COVID-19. The trial found that the antibody drug reduced the rate of hospitalizations in patients with the disease. Regeneron has also filed for an EUA for its monoclonal antibody cocktail.
The UK’s Drug Safety Research Unit has found that Gilead Sciences’ remdesivir features a “favorable” benefit-risk profile for patients with COVID-19. According to the research unit, patients who were treated with the drug had a faster recovery and reductions in ventilation and oxygen requirements. Because of the limited available safety data, the unit was unable to determine if the reported adverse events were related to COVID-19 or the treatment.
An HIV-1 antiviral drug combination from AbbVie, consisting of lopinavir and ritonavir, did not reduce all-cause mortality in the UK’s RECOVERY trial of hospitalized patients with COVID-19.
The head of Operation Warp Speed, Moncef Slaoui, has said that early efficacy data on COVID-19 vaccines will be available in the next few months. According to Slaoui, Pfizer’s and Moderna’s vaccine data will come in the first wave in November or December, and Johnson & Johnson may report interim results in December. He also stated that enough vaccine doses will be available to vaccinate 30 million Americans at the end of the year.
The CoVIg Plasma Alliance has enrolled the first of up to 500 patients in its international phase 3 trial of blood plasma as a COVID-19 treatment. The trial will take place in the U.S., Mexico and 16 other countries. Led by Takeda and CSL Behring, the alliance includes two other biotech companies that will contribute their plasma therapies. Participants will receive remdesivir in addition to a hyperimmune globulin treatment. The alliance hopes to have results before the end of the year.
Final results are in on the National Institute of Allergy and Infectious Diseases’ (NIAID) phase 3 trial of Gilead Sciences’ treatment remdesivir and show the antiviral was superior to placebo in hospitalized patients who received standard of care. NIAID data show mortality was reduced by 70 percent, patients recovered five days faster and disease progression was reduced.
NIAID also has announced a phase 3 trial to evaluate hyperimmune globulin products as a treatment for hospitalized adults with COVID-19. The trial will test four products, including Emergent BioSolutions’ COVID-HIG, and compare the treatment combined with remdesivir to placebo combined with remdesivir. Emergent says it also is planning additional trials of COVID-HIG for potential use in other patient populations or individuals at high risk of exposure.
France is looking to enroll up to 25,000 adults in a series of phase 2 and 3 trials of COVID-19 vaccine candidates. The trials will start in October at 24 hospitals in France and will be headed by Inserm, the country’s public research body.
AstraZeneca, which recently paused all global trials of its COVID-19 vaccine candidate, AZD1222, has resumed a phase 1/2 clinical trial of the vaccine in Japan. The British pharmaceutical company paused all trials of the vaccine following an adverse event that occurred in one patient. While AstraZeneca has also resumed its vaccine trials in the UK, India, Brazil and South Africa, the U.S. trial is still on pause as the FDA examines the adverse event.
Dr. Reddy’s Laboratories’ proposal to conduct a large study of Russia’s Sputnik-V COVID-19 vaccine in India has been declined by India’s Central Drugs Standard Control Organization. India has instead asked Dr. Reddy’s to test the vaccine in a smaller trial first.