Regeneron's COVID-19 antibody therapy yields 'encouraging' trial data

 

• Announcing the results from an ongoing Phase 1/2/3 clinical trial for its antibody cocktail, Regeneron Pharmaceuticals (NASDAQ:REGN) calls the initial data for the therapy in hospitalized COVID-19 patients requiring low-flow oxygen as encouraging.
• The primary clinical objective of the initial analysis was to determine if there was sufficient efficacy to warrant continuing the trial (futility analysis). According to the company, the results have passed the futility analysis (p<0.3 one-sided) with seronegative patients treated having a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2).
• In seronegative patients (n=217), the antibody cocktail has reduced the time-weighted average daily viral load, while its clinical and virologic benefit was limited in seropositive patients (n=270).
• The patients appear to have well tolerated the antibody cocktail, casirivimab, and imdevimab, with the incidence of serious adverse events standing at 21% for high dose, 20% for low dose, and 24% for placebo.
• However, noting that the results are robust, George D. Yancopoulos, the President/CEO of Regeneron, highlights the need for a much larger trial to thoroughly prove the effect given the small data set of events evaluated.
• With FDA authorization received for emergency use in November, the company has an agreement with the U.S. government for approximately 300,000 doses (2,400 mg) of the treatment for outpatient use. Regeneron is on track to manufacture the doses by January 2021, while discussions continue for additional supplies for the government, a statement from the company said.
• Yet, last week the Wall Street Journal reported that as much as 80% of weekly supplies of antibody therapies for COVID-19 are left unused at healthcare facilities, citing the officials from Operation Warp Speed.
• https://seekingalpha.com/news/3647800-regenerons-covidminus-19-antibody-therapy-yields-encouraging-trial-data