ISM8969 / Insilico Medicine, Hygtia Therapeutics - LARVOL DELTA

InSilico Medicine…is pleased to announce that, ISM8969/HT-001, an innovative oral NLRP3 inhibitor co-developed with Hygtia Therapeutics Co., Ltd (’Hygtia Therapeutics’), has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of China for the treatment of Parkinson’s disease (HKEXnews) - "The clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ISM8969/HT-001 in healthy subjects and preliminary efficacy of ISM8969/HT-001 in patients with Parkinson's disease, establishing a foundation for its subsequent clinical development."

New trial • Parkinson's Disease

A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM8969 (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: InSilico Medicine Hong Kong Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Obesity • CRP

Study Evaluating ISM8969 in Healthy Adult and Elderly Participants and Obese Adult Participants at Risk of Cardiovascular Disease (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: InSilico Medicine Hong Kong Limited

New P1 trial • Cardiovascular • Obesity • CRP

Insilico Medicine and Hygtia Therapeutics Enter New Global Strategic Collaboration to Co-Develop Novel Brain Penetrant NLRP3 Inhibitor for CNS Diseases treatment (PRNewswire) - "Under the terms of the agreement, Insilico grants Hygtia Therapeutics 50% worldwide rights to research, develop, register, manufacture, and commercialize ISM8969. In return, Insilico is eligible to receive upfront and milestone payments totaling up to USD$66 million, including an initial upfront payment of USD$10 million expected within 30 days of the agreement's effective date...Reflecting the joint commitment to the program's success, Insilico will lead the initial clinical development, including IND submission and execution of the Phase 1 clinical trial for the Parkinson's disease indication."

Licensing / partnership • CNS Disorders • Parkinson's Disease

Insilico Medicine...announced that ISM8969, an orally available NLRP3 inhibitor targeting inflammation and neurodegenerative disorders, has recently received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA), intended for the treatment of Parkinson’s Disease. (Eurekalert) - "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."

IND • New P1 trial • Parkinson's Disease

Insilico Medicine Advances Parkinson’s Therapy with IND-Enabling Milestone for AI-Driven Oral NLRP3 Inhibitor ISM8969 (Bioengineered) - "This novel inhibitor has successfully completed Investigational New Drug (IND)-enabling studies, positioning ISM8969 to enter clinical trials as a potential transformative therapy for Parkinson’s disease (PD) in the fourth quarter of this year."

New trial • Parkinson's Disease