Ascletis Pharma Inc. (ASCLF.PK) Monday announced that the China National Medical Products Administration or NMPA has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus or RSV infection.
There is no effective drug for treatment globally so far for RSV infection. Across the world, RSV affects an estimated 64 million people and causes 160,000 deaths each year.
ASC10 is an oral double prodrug. After oral administration, ASC10 is rapidly and completely converted in vivo into the active metabolite ASC10-A, also known as ß-D-N4-hydroxycytidine (NHC) or EIDD-1931.
Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, said, “RSV poses a persistent threat to infants and the elderly population, and so far there is no effective drug available worldwide. We are glad that ASC10 has obtained the China NMPA approval to conduct a Phase IIa study to treat RSV infection in patients, which is a new milestone of Ascletis’ R&D in treatment for viral diseases. Preclinical research showed that ASC10-A is a potent inhibitor against RSV both in vitro and in vivo, and we will accelerate the Phase IIa clinical study to benefit patients worldwide.”
The company noted that dosage of 800 mg ASC10, twice daily, based on available data, was selected to conduct a randomized, double-blind, placebo-controlled Phase IIa study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of ASC10 tablets in patients with mild or moderate RSV infection.
Ascletis in January 2023 obtained the approval of conducting a Phase IIa clinical trial for ASC10 to treat RSV infection from the U.S. Food and Drug Administration.
The company has been granted a patent of ASC10 and its derivatives, and their uses to treat multiple virus infections by the United States Patent and Trademark Office (USPTO), including SARS-CoV-2, monkeypox virus and RSV.
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