Ascletis Cleared By FDA To Begin Trial On Monkeypox Antiviral

The US FDA has approved the Investigational New Drug (IND) application for Ascletis Pharma’s ASC10, an antiviral designed to treat monkeypox. This clears the company to begin a Phase 1b trial in monkeypox patients, where ASC10 will be investigated at an 800 mg twice-daily dosage. 

The go-ahead from the FDA follows an August approval by China’s drug regulator which clears Ascletis to begin a trial in COVID-19.

Related Article: Growing Number of Monkeypox Tests Available to Researchers

No Approved Treatment For Monkeypox

Over 79,000 cases of monkeypox have been confirmed globally in 110 countries, according to WHO statistics. The virus causes smallpox-like symptoms but is less contagious than smallpox and causes less severe illness. 

There is an urgent need to develop a safe, effective, and affordable solution for monkeypox as there are no approved treatments for the disease, stressed Ascletis CEO and founder Dr. Jinzi J. Wu. 

“This IND approval of ASC10 for monkeypox from the U.S. FDA further validates Ascletis’ in-house R&D capabilities on viral diseases, and it will accelerate our efforts to better address the global challenge imposed by the widespread monkeypox,” he said in a statement. 

While there are no approved treatments, vaccines for smallpox have been found to be effective against monkeypox, given the similarities between the viruses. Pfizer has developed the JYNNEOS vaccine which the US CDC recommends for individuals at a high risk for infection. Moderna, on the other hand, announced it was beginning preclinical work as part of a push for next-generation RNA-based vaccines beyond COVID-19.

Potent Antiviral Activity Against Monkeypox

ASC10 is an oral double prodrug made up of ASC10 and the prodrug molnupiravir. Both components are converted in vivo into the active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931. 

ASC10 works by targeting RNA-dependent RNA polymerase needed for viral replication. Preclinical studies indicate that ASC10-A exerts potent antiviral activities on a broad spectrum of viruses including monkeypox and variants of SARS-CoV-2, the virus that causes COVID-19.

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Joy Lin

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