Vir and Alnylam Identify RNAi Therapeutic Development Candidate, VIR-2703 (ALN-COV), Targeting SARS-CoV-2 for the Treatment of COVID-19

Vir Biotechnology, Inc. (Nasdaq: VIR) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced the selection of a development candidate (DC) for VIR-2703 (also referred to as ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 genome. The companies plan to soon meet with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to discuss a potential accelerated path for filing an Investigational New Drug (IND) or IND equivalent application at or around year-end 2020, less than a year since program initiation. The companies plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.

In its discovery efforts, Alnylam synthesized over 350 small interfering RNAs (siRNAs) – the molecules that mediate RNAi – targeting highly conserved regions of the SARS-CoV-2 genome, which were then analyzed bioinformatically and assessed in in vitro potency assays. Multiple highly potent siRNAs were identified that demonstrated a 3-log reduction of viral replication in an in vitro SARS-CoV-2 live virus model conducted by Vir. In dose-response assays, VIR-2703 was shown to have an effective concentration for 50% inhibition (EC50) of less than 100 picomolar and an EC95 of less than 1 nanomolar in the SARS-CoV-2 live virus model measuring inhibition of infectious virion production. Further, VIR-2703 has predicted reactivity against greater than 99.9 percent of the over 4300 SARS-CoV-2 genomes currently available in public databases that meet analysis requirements, and is also predicted to have reactivity toward the SARS-CoV genome from the 2003 SARS outbreak. With this DC selection, Vir and Alnylam will work closely together to generate the data required to enable rapid commencement of clinical studies.

“Vir is committed to applying industry-leading technologies in our fight against COVID-19. Our fruitful and expansive collaboration with Alnylam has rapidly led to identification of a development candidate targeting SARS-CoV-2,” said George Scangos, Ph.D., CEO of Vir. “With this candidate now in hand, we will further accelerate our efforts and plan to begin studies in humans at or around year-end. Our ultimate goal would be to provide rapid worldwide access, if approved, to an effective therapeutic to combat COVID-19.”