INSILICO (03696): AI-driven NLRP3 inhibitor ISM8969 clinical trial application approved by FDA Has "best-in-class" potential

INSILICO (03696) announced that its clinical trial application for the oral NLRP3 inhibitor ISM8969, used for the treatment of inflammatory and neurodegenerative diseases, has been approved by the Food and Drug Administration (FDA) of the United States for the treatment of Parkinson's disease. The upcoming Phase I clinical study aims to evaluate the safety, tolerability, and pharmacokinetics of ISM8969 in healthy individuals and to find the clinically recommended optimal dose for further studies. ISM8969, as a potential best-in-class NLRP3 inhibitor, was discovered and optimized through INSILICO's proprietary generative chemistry engine, Chemistry42. The molecule has demonstrated excellent efficacy and good safety in preclinical studies, as well as significant anti-inflammatory activity in various disease models. It is worth noting that ISM8969 has ideal blood-brain barrier (BBB) permeability, allowing it to cross the BBB and potentially benefit the treatment of neuroinflammatory diseases. Based on promising preclinical data, INSILICO has identified ISM8969 as the preclinical candidate compound for this project and has extensively evaluated the molecule in various neurological disease models.