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Alnylam and Vir plan gene-silencing attack on COVID-19 virus

Drug could be ready for clinical trials before the end of the year

Alnylam

Alnylam and Vir Biotechnology have joined forces on an RNA interference (RNAi) drug for coronavirus that they say could be ready for clinical trials before the end of the year.

After first starting work on the project in March, the two partners say they have now identified an RNAi candidate that switches off a key gene in SARS-CoV-2, the virus that causes COVID-19, and interferes with its ability to replicate itself.

They are seeking accelerated approval from the FDA to treat healthy volunteers with the drug – called VIR-2703/ALN-COV – that was selected out of around 350 RNAi drugs that targeted different portions of the coronavirus genome. Their agreement covers the development of up to four RNAi drug candidates.

The drug would be delivered by inhalation directly into the lungs of patients with COVID-19, and could have potential both to treat active infections and also as a preventive measure, according to Alnylam and Vir.

In initial studies, ALN-COV was found to inhibit viral replication by 50% at a concentration of less than 100 picomoles, with 95% inhibition at 1 nanomolar, in live virus assays, which the biotechs say should be potent enough to block the virus in vivo.

“To our knowledge, this is one of the most potent direct-acting antivirals targeting SARS-CoV-2 reported to date,” said John Maraganore, Alnylam’s chief executive. If trials do start before year-end, it will be breakneck speed for a drug development programme.

The Alnylam and Vir partnership also follows an alliance announced last week between Sarepta and the US Department of Defense to find antisense oligonucleotides against SARS-CoV-2, which are designed to switch off the activity of genes but work via a different mechanism.

There are currently no approved treatments or vaccines for COVID-19, although Gilead Sciences has just claimed emergency use authorisation (EUA) from the FDA for its antiviral drug remdesivir. The US regulator has previously granted EUAs for malaria drugs hydroxychloroquine and chloroquine for severely ill coronavirus patients.

Gilead’s drug is meanwhile under regulatory review in Europe and Japan after showing preliminary efficacy in the ACTT study conducted by the National Institute for Allergy and Infectious Diseases (NIAID), reported last week.

Alnylam is a specialist in the development of RNAi treatments and currently has two FDA-approved drugs – Givlaari (givosiran) and Onpattro (patisiran) – for the rare genetic diseases acute hepatic porphyria (AHP) and polyneuropathy caused by hATTR amyloidosis, respectively.

Vir meanwhile focuses on developing drugs for infectious diseases, and is already collaborating with Alnylam on VIR-2218, an RNAi drug for hepatitis B virus (HBV) designed to switch off the production of proteins including hepatitis B virus surface antigen (HBsAg), which is in phase 2 development.

Last month it signed a $250m deal with UK drugmaker GlaxoSmithKline that will accelerate development of monoclonal antibody-based therapies for COVID-19.

That deal will initially focus on two candidates - VIR-7831 and VIR-7832 – that target the SARS-CoV-2 spike protein and are effective at neutralising the virus in live virus-cellular assays. Vir has also teamed up with WuXi Biologics to develop a COVID-19 antibody.

Article by
Phil Taylor

5th May 2020

From: Research

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