Insilico Medicine (HK:3696), a clinical-stage drug discovery and development company driven by generative artificial intelligence (AI), announced on Friday that ISM8969, an orally available NLRP3 inhibitor targeting inflammation and neurodegenerative disorders, has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) for the treatment of Parkinson's Disease.

The Phase I clinical trial plans to evaluate the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers, and to identify the optimal dose level(s) to be recommended for further investigation.

ISM8969 was discovered and optimised using Insilico's Chemistry42, a comprehensive generative chemistry engine consisting of multiple applications across the drug design and discovery stages.

To accelerate the global development of ISM8969, Insilico Medicine has entered into a co-development collaboration agreement which grants Hygtia Therapeutics worldwide rights to research, develop, register, manufacture, and commercialise ISM8969, with both parties each holding 50% of the global rights and interests to the programme. In return, Insilico is eligible to receive up to USD66m in upfront and milestone payments.