New drug from COVID-19
Vir Biotechnology (NASDAQ:VIR) shares jumped more than 30% in trading in New York.
Shares rose after the company said its experimental treatment COVID-19, being developed with GlaxoSmithKline PLC ADR (NYSE:GSK)'s pharmaceutical drug, had significantly reduced hospitalizations and deaths among high-risk adults.
The night before, the companies reported that the monoclonal antibody drug, VIR-7831, reduced mortality or hospitalisation by 85% compared with placebo in clinical trials, MarketWatch writes.
The developers now intend to apply for emergency approval to the US Food and Drug Administration (FDA), as well as to regulatory authorities in other countries.
GlaxoSmithKline shares are down 0.06% so far on the premarket.
An independent monitoring committee has recommended a premature halt to trials of the drug, intended for the early treatment of COVID-19 in adults at high risk of hospitalisation, because interim analysis has shown it to be highly effective. The recommendation was based on data from 583 patients.
The companies also said that a separate in vitro study showed that the drug remains effective against new variants of the coronavirus identified in the UK, South Africa and Brazil.
If the FDA approves the application, the treatment will be added to existing antibody-based drugs after emergency approval was granted in November for drugs developed by Eli Lilly (NYSE:LLY) and Regeneron (NASDAQ:REGN).
Monoclonal antibodies could play a key role in protecting people less susceptible to vaccines or those who are contraindicated in vaccinating against SARS-CoV-2, such as cancer patients with suppressed immune systems, Bloomberg notes.
Also, one expert thinks the potential for sales of a third antibody drug could be limited this year.
A separate study of the efficacy of VIR-7831 in hospitalized patients was stopped last week after the National Institutes of Health said the treatment may not benefit patients.