Insilico Medicine has announced plans to commence clinical trials of its orally available 3CLpro inhibitor ISM3312 in China for the treatment of Covid-19 patients.

The latest move comes after the company received approval from the China National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application submitted for ISM3312.

The clinical trial will explore the safety, tolerability, and pharmacokinetic profile of the drug designed by Insilico’s generative chemistry AI platform, Chemistry42.

In addition, the trial will explore ISM3312’s safety and efficacy in different subgroups of patients with Covid-19.

This is expected to provide an alternative option for health management in the post-pandemic period.

The highly selective small molecule inhibitor ISM3312 attaches to the target protein in an irreversible, covalent binding mode.

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Its new molecular structure provides wide anti-coronavirus activity, potential drug-resistant mutations, and single agent oral bioavailability.

Insilico Medicine co-CEO and chief scientific officer Feng Ren said: “Insilico fully utilised its unique features in this internal Covid research and development (R&D) programme by leveraging AI capabilities with R&D expertise to design an innovative 3CLpro inhibitor with novel structure and molecular backbone.

“ISM3312 has significant differences and distinct advantages from existing 3CL protease inhibitors. We are committed to accelerating clinical trials through fast-tracking development policy of the treatment for Covid-19 to benefit patients worldwide.”

ISM3312 significantly minimised viral load in lung tissue and decreased inflammation in lungs in preclinical trials.

Insilico Medicine founder and CEO Alex Zhavoronkov said: “We’re extremely happy to announce that our second small molecule therapeutic generated using generative AI is now entering human clinical trials and there is a very clear timeline to demonstrate the discovery and development cycle.”