VIR-2703 is a result of the recently announced expansion of the firms’ multi-target existing collaboration for the development and commercialisation of RNAi therapeutics for infectious diseases. The partnership was expanded to include SARS-CoV-2, the virus behind the novel coronavirus infection.
Vir Biotechnology and Alnylam Pharmaceuticals said that they intend to meet with the US Food and Drug Administration (FDA) and other regulatory bodies shortly to discuss a potential accelerated path for filing an investigational new drug (IND) or IND equivalent application for VIR-2703 at or around this year-end.
The partners plan to advance the investigational RNAi therapeutic as an inhalational formulation for the potential treatment and/or prevention of novel coronavirus.
Alnylam Pharmaceuticals is said to have synthesised more than 350 small interfering RNAs (siRNAs) as part of its discovery efforts. The company said that it had targeted highly conserved regions of the SARS-CoV-2 genome, which were then bioinformatically analysed and studied in in vitro potency assays.
According to the partners, multiple highly potent siRNAs were identified that showed a three-log reduction of viral replication in an in vitro SARS-CoV-2 live virus model conducted by Vir Biotechnology.
VIR-2703 was demonstrated to have an effective concentration for 50% inhibition (EC50) of less than 100 picomolar in dose-response assays. It also showed an EC95 of less than one nanomolar in the SARS-CoV-2 live virus model that measured the inhibition of infectious virion production.
The investigational RNAi therapeutic is also said to have predicted reactivity against more than 99.9% of more than 4300 SARS-CoV-2 genomes that are available currently in public databases that meet analysis requirements. It is also predicted to have reactivity towards the SARS-CoV genome from the 2003 SARS epidemic, said the partners.
Alnylam Pharmaceuticals CEO John Maraganore said: “To our knowledge, this is one of the most potent direct-acting antivirals targeting SARS-CoV-2 reported to date.
“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 Biotechnology and Alnylam Pharmaceuticals said that they will work closely to generate the data needed for enabling the rapid commencement of clinical studies for the investigational RNAi therapeutic.
Vir Biotechnology CEO George Scangos said: “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 the identification of a development candidate targeting SARS-CoV-2.
“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.”