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Regeneron Pharmaceuticals Inc (NASDAQ:REGN), the New York-headquartered biotechnology firm, has said that the company has garnered “encouraging data” from the Phase 1/2/3 clinical trials of the Regeneron Covid-19 antibody cocktail. The trials of the antibody therapy, casirivimab and imdevimab, were conducted on hospitalised coronavirus patients requiring low-flow of oxygen. Regeneron has claimed the antibody cocktail as the first therapy that has demonstrated “anti-viral effect” in hospitalised Covid-19 patients.
The oxygen level of the patients who were administered with the antibody cocktail was saturated above 93 per cent via nasal cannula, a simple face mask or a similar device. Randomisation technique was incorporated for selecting the patients who will receive the antibody cocktail, out of which 74 per cent received systemic corticosteroids, while 67 per cent received remdesivir.
(Image source: ©Kalkine Group 2020)
Encouraging data
The analysis conducted by Regeneron has been especially designed for the coronavirus patients who had not yet mounted their respective immune response to SARS-CoV-2, the company said. The initial analysis has been done with a primary clinical objective to adjudge the sufficient efficacy in the coronavirus patients that can permit the continuation of the trial.
The requirement of mechanical ventilation or the risk of death reduced by nearly half following the antibody cocktail administration with the benefit of the therapy being recognised after one week of the treatment.
According to Regeneron, two antibody cocktails that were administered to the hospitalised Covid-19 patients were “well-tolerated” with the incidence of serious adverse events surfacing at 21 per cent, 20 per cent and 24 per cent for high dose, 20 per cent for low dose and 24 per cent for placebo.
Antibody usage
The United States Food and Drug Administration (FDA) has already granted an emergency use authorisation (EUA) for Regeneron antibody cocktail in November. The EUA has been granted to be administered in high-risk patients with confirmed Covid-19 cases that were not hospitalised. The safety and efficacy of the antibody therapy has been evaluated in multiple clinical trials.
The Regeneron antibody cocktail is presently being probed for the treatment of non-hospitalised patients in the Phase 3 clinical trials. Regeneron is underway to produce nearly 300,000 doses (2,400 mg) of the antibody under an agreement with the United States government for the outpatient use under the EUA. As per Regeneron, the company is in deliberations with the US government with regards to additional doses as the firm is on schedule to manufacture these doses in January 2021.
Regeneron shares
Regeneron Pharmaceuticals Inc share price didn’t react sharply to the development so far. The company has notified the encouraging data in Covid-19 antibody development on 29 December.
According to the latest trading data available with the Nasdaq, the stock of Regeneron ended marginally higher at $484.22, up 0.26 per cent on 29 December. At around 1000 (GMT - 5), Regeneron shares were trading at $485.07, up 0.18 per cent.
Regeneron Pharmaceuticals Inc (30 December)
(Source: EODHD/Others, Thomson Reuters)
