Regeneron says coronavirus treatment plan looks promising

Henrietta Strickland
October 1, 2020

The Food and Drug Association (FDA), a federal agency which oversees protecting and promoting public health in the USA, can authorize a drug for emergency use before completing a review for formal approval.

The FDA can authorize emergency use of a drug before completing its review for a formal approval. Regeneron declined to comment on when those trial results are expected.

"It is unclear, though possible, that the Regeneron cocktail could work in a hospital setting where the patient is already severely ill and has a high viral load", Jefferies analyst Michael Yee said in a research note. It is concurrently running late-stage trials for hospitalized COVID-19 patients and for the drug's potential as a prophylaxis or preventative treatment.

The US biotech firm Regeneron said Tuesday its antibody cocktail against the coronavirus reduced viral load and recovery time in non-hospitalized Covid-19 patients during an early-stage clinical trial.

Price Action: Regeneron shares gained nearly 3% to $591 in the after-hours session after closing 0.3% higher on Tuesday.

"The greatest treatment benefit was in patients who had not mounted their own effective immune response". That suggests the REGN-COV2 could help patients whose own immune system is not strong enough to combat the virus, Regeneron said.

Regeneron uses a multi-antibody strategy to decrease the chances that the virus will mutate in order to evade the blocking action of a single antibody, an approach the company detailed in a recent study in Science.

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, diminishing the ability of mutant viruses to escape treatment and protects against spike variants in the human population. Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo.

Regeneron (REGN) said that the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its REGN-COV2 also showed positive trends in reducing medical visits.

The descriptive analysis included the first 275 patients enrolled in the trial and was created to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment.

"The data are favorable for seronegative patients", Yee said.

In July, Regeneron signed a 0 million contract with the government to supply REGN-COV2 should the trials prove to be successful.

Swiss drugmaker Roche Holding AG last month agreed to boost overall manufacturing capacity for REGN-COV2 by at least three-and-a-half times.

Other reports by Click Lancashire

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