ASCLF - Ascletis gets Chinese drug regulator nod to start trial of oral COVID therapy

Ascletis Pharma ( OTCPK:ASCLF ) said China's National Medical Products Administration (NMPA) approved its investigational new drug (IND) application to start a trial of oral drug ASC11 for COVID-19.

The goal of the phase 1 trial, which is expected to be completed within Q1 2023, is to identify a safe and efficacious dose for the pivotal phase 2/3 in patients with COVID-19.

In addition, the phase 1 study will determine if ASC11 needs to be boosted by ritonavir or not.

The Chinese company said that in antiviral cellular assays with infectious SARS-CoV-2, ASC11 showed much higher potency against the virus than other 3CLpro inhibitors including nirmatrelvir, Shionogi's ( OTCPK:SGIOF ) ( OTCPK:SGIOY ) oral drug S-217622, Pardes Biosciences' ( PRDS ) oral therapy PBI-0451, and Enanta Pharmaceuticals' ( ENTA ) oral medicine EDP-235.

Pfizer's ( PFE ) Paxlovid consists of (nirmatrelvir and ritonavir).

"The IND approvals of ASC11 from both China NMPA and U.S. FDA mark a great recognition to our in-house R&D capabilities," said Ascletis Founder, Chairman and CEO Jinzi Wu.

Ascletis added that ASC11 has potent antiviral activity against several Omicron variants such as BA.1 and BA.5. In the animal model with infectious SARS-CoV-2, ASC11 also showed potent antiviral activity, according to the company.

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