- Alnylam Pharmaceuticals and Vir Biotechnology said Monday that, after evaluating hundreds of potential drugs for COVID-19, they have selected one to move forward into human testing.
- In theory, the drug would interfere with the genetic instructions that the novel coronavirus, which causes COVID-19, uses to replicate. According to Alnylam and Vir, preclinical tests indicated that their drug, even at low concentrations, is highly potent against the virus.
- The companies said they want to meet soon with regulatory authorities, including the Food and Drug Administration, to discuss accelerating their drug's development timeline. They hope to submit sometime around the end of the year the application that could allow human testing to begin.
Alnylam and Vir had been partners well before the coronavirus pandemic hit. In late 2017, they entered into a agreement that gave Vir the power to license a handful of infectious disease drugs made with Alnylam's RNA interference technology.
The companies chose to expand that agreement in March, amid rising global concerns over the spread of the virus, named SARS-CoV-2. Under the new deal terms, the pair would advance one or more RNAi drugs for SARS-CoV-2 — and potentially other members of the coronavirus family — using Vir's infectious disease expertise and Alnylam's know-how for creating these medicines and getting them into the lungs.
Alnylam designed and made more than 350 small interfering RNA molecules that target all the available genomes for SARS-CoV-2 and its close relative, the SARS virus. Among these drugs, Alnylam and Vir said there were multiple that, in preclinical tests, appeared to substantially reduce viral replication of SARS-CoV-2.
The drug chosen to move forward was shown to be potent against the virus even at very small concentrations. In fact, the numbers provided by Alnylam and Vir suggest the drug could be more potent than Gilead's remdesivir, a closely watched antiviral medication that was just recently cleared by the FDA for emergency use in treating COVID-19.
Additionally, Alnylam and Vir said the drug they're advancing should be effective against more than 99.9% of the 4,300-plus SARS-CoV-2 genomes currently available in public databases that meet analysis requirements. It also looks like the drug should work on the SARS-CoV genome from the 2003 SARS outbreak, according to the companies.
"With this candidate now in hand, we will further accelerate our efforts and plan to begin studies in humans at or around year-end," said George Scangos, CEO of Vir, in a May 4 statement. "Our ultimate goal would be to provide rapid worldwide access, if approved, to an effective therapeutic to combat COVID-19."
As part of their expanded agreement, Alnylam and Vir may also choose to develop up to three more drug candidates for COVID-19, and possibly other coronavirus-related diseases.
Aside from its work with Alnylam, Vir has also been investigating the use of monoclonal antibodies to treat COVID-19. The San Francisco-based company has teamed up with China's WuXi Biologics as well as the big biotech Biogen to develop and manufacture these antibodies.
Vir's antibodies also attracted interest from British drug giant GlaxoSmithKline, which recently took a $250 million stake in the company to help speed up its drug development and to gain access to its technology.