Ascletis announced that the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application of ASC10 for monkeypox indication. Based on available data, 800 mg ASC10 twice daily was approved by the FDA to conduct a Phase Ib, randomized, double blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in patients with monkeypox virus disease.
ASC10 is an oral double prodrug. After oral administration, both ASC10 and single prodrug molnupiravir are rapidly and completely converted in vivo into the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931.
Preclinical studies show that ASC10-A has broad spectrum antiviral activities including potent activities against both monkeypox and SARS-CoV-2 viruses. Ascletis has filed multiple patent applications globally for ASC10 and its use in viral diseases including monkeypox virus infection.
Monkeypox virus is an orthopoxvirus that causes a disease with symptoms similar to smallpox. As of November 15, 2022, over 79,000 confirmed cases have been reported globally and monkeypox virus has spread in 110 countries, according to data from World Health Organization (WHO). In particular, a total of 28,947 confirmed monkeypox cases have been reported in the U.S. WHO assesses the risk of monkeypox virus in the Region of the Americas as high.