Ascletis Pharma has received approval from the China National Medical Products Administration (NMPA) to initiate a Phase IIa clinical trial of 800mg ASC10 for the treatment of respiratory syncytial virus (RSV) infection.
The placebo-controlled, double-blind, randomised study will evaluate the antiviral activity of ASC10 tablets given twice daily to patients with mild or moderate RSV infection.
It will also assess pharmacokinetics properties of ASC10 along with safety and tolerability.
An oral double prodrug, ASC10 is converted into the active metabolite ASC10-A also known as β-D-N4-hydroxycytidine or EIDD-1931, in vivo.
Ascletis Pharma founder, chairman and CEO Dr Jinzi Wu 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 United States Patent and Trademark Office (USPTO) has granted patent to Ascletis’ ASC10 and its derivatives for treating SARS-CoV-2, monkeypox virus along with RSV.
The company also focuses on discovering various therapies for non-alcoholic steatohepatitis and oncology.