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Alnylam, Vir aim for year-end FDA filing to start Covid-19 antiviral drug trial

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Fresh off the heels of the first Food and Drug Administration authorization for a direct-acting antiviral against SARS-CoV-2, two prominent biotech companies said they have identified a candidate of their own for clinical development.

San Francisco-based Vir Biotechnology and Cambridge, Massachusetts-based Alnylam Pharmaceuticals said Monday that they had chosen the drug VIR-2703 – also known as ALN-COV – for clinical development, with a plan to file an application with the FDA to start a clinical trial by the end of the year.

Shares of Vir rose 8.4% on the Nasdaq Monday morning following the news, while shares of Alnylam rose 4.4%.

VIR-2703 is an RNA interference-based therapy that the companies plan to develop as an inhaled drug for treating or preventing Covid-19, the disease caused by SARS-CoV-2. The drug was screened from among 350 small interfering RNAs that Alnylam synthesized to target certain regions of the virus’ genome. Lab testing has indicated significant potency against the virus and predicted reactivity against nearly 100% of the more than 4,300 SARS-CoV-2 genomes as well as the 2003 SARS coronavirus genome, though it remains to be determined whether it can have efficacy in humans.

“To our knowledge, this is one of the most potent direct-acting antivirals targeting SARS-CoV-2 reported to date,” Alnylam CEO John Maraganore said in a statement. “As this pandemic continues to unfold, we are committed to acting with the utmost urgency to broaden and accelerate our efforts to develop investigational RNAi therapeutics against Covid-19 and, potentially, future coronavirus-mediated diseases.”

Vir has partnerships with a number of companies to develop drugs against Covid-19. Last month, British drugmaker GlaxoSmithKline announced a $250 million equity investment in Vir under its own Covid-19 collaboration with the company. And also last month, it reached a $362 million contract manufacturing deal with Samsung Biologics, also focused on Covid-19.

The FDA granted an emergency use authorization, or EUA, for Gilead Sciences’ intravenous antiviral remdesivir for Covid-19 last week, following the success of a randomized, controlled clinical trial conducted by the National Institute of Allergy and Infectious Diseases.

Photo: gorodenkoff, Getty Images

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