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Ascletis Pharma’s monkeypox treatment has received approval from the US Food and Drug Administration (FDA) for a New Drug (IND) application.
The FDA made its decision based on the available data, and Askletis can now proceed to a Phase 1b clinical trial to evaluate the safety, tolerability, efficacy and pharmacokinetics of the pill in monkeypox patients with 800 mg of ASC10 taken twice daily. viral disease.
ASC10 is an oral double pre. After oral administration, both ASC10 and the prodrug molnupiravir are rapidly and completely converted in vivo to the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931.
A Study of Ascletis: A Smallpox-Like Ape
Preclinical studies have shown that ASC10-A has broad-spectrum antiviral activity, including potent activity against monkeypox and SARS-CoV-2 viruses. Ascletis has filed several patent applications worldwide for ASC10 and its use in viral diseases, including monkeypox virus infection.
In his research through the World Health Organization (WHO), Askletis identified the monkeypox virus as an orthopoxvirus that causes a disease with symptoms similar to smallpox.
As of yesterday (November 15), there have been more than 79,000 confirmed cases worldwide, and the monkeypox virus has spread to 110 countries. Specifically, with a total of 28,947 confirmed cases of monkeypox in the United States, WHO rates the risk of monkeypox in the Americas as high.
The FDA further approves Ascletis
In a study funded by Askletis and conducted at the IIT Research Institute (IITRI) at the Illinois Institute of Technology in Chicago, data from an in vitro antiviral assay against infectious monkeypox virus showed that ASC10-A has potent antiviral activity against monkeypox virus. ASC10 has the potential to effectively treat monkeypox virus infection.
Researchers at the National Institute of Infectious Diseases, Tokyo, Japan, tested 132 drugs and the results showed that molnupiravir (active metabolite ASC10-A) and two other drugs had strong cellular antiviral activity in an assay of the infectious monkeypox virus. The remaining 129 drugs, including remdesivir, favipiravir, sofosbuvir and ribavirin, have no antiviral activity against the monkeypox virus, Ascletis said.
Jinzi J. Wu, founder, chairman and CEO of Ascletis, said: “There is an urgent need to develop a safe, effective and affordable solution to treat monkeypox worldwide. This IND approval of ASC10 against monkeypox by the US FDA validates Ascletis’ in-house research capabilities in viral diseases and accelerates our efforts to better address the global challenge posed by this widespread monkeypox.
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