Insilico Medicine and Hygtia Biology enter into co-development pact for CNS inhibitor ISM8969 with HKD 78M upfront
Insilico Medicine and Hygtia Biology enter into co-development agreement to advance global development of ISM8969. Under the agreement, both parties hold 50% global rights in the project, with Insilico Medicine eligible to receive over HKD 500 million in upfront and milestone payments.
Insilico Medicine will lead the IND submission and Phase I clinical trial for ISM8969, after which Hygtia Biology will be responsible for subsequent clinical development, regulatory submissions, and commercialization.
ISM8969 is a novel, orally available NLRP3 inhibitor with blood-brain barrier penetration properties, discovered and optimized through Insilico Medicine's generative chemistry platform Chemistry42. Preclinical studies have demonstrated its excellent efficacy, favorable safety profile, and superior blood-brain barrier penetration capability.
On January 20, Insilico Medicine (03696.HK), a generative artificial intelligence-driven clinical-stage biotech company, and Hygtia Biology jointly announced a co-development agreement for the ISM8969 project. Through this exclusive strategic partnership, the two companies will jointly accelerate the global development of ISM8969, a novel, orally available NLRP3 inhibitor with blood-brain barrier penetration properties, intended for the treatment of central nervous system diseases.
Under the agreement, Insilico Medicine will grant Hygtia Biology a 50% right to research, develop, register, manufacture, and commercialize ISM8969 worldwide. Meanwhile, Insilico Medicine is eligible to receive over HKD 500 million in upfront and milestone payments, including an upfront payment of HKD 78 million expected to be made within 30 days after the agreement becomes effective.
To reflect the shared commitment to the project, Insilico Medicine will lead the early-stage clinical development of ISM8969, including the completion of the Investigational New Drug (IND) submission and the Phase I clinical trial targeting Parkinson's disease. Hygtia Biology will spearhead subsequent global clinical studies, regulatory registration, and commercialization efforts.
The NLRP3 inflammasome is a key component of the innate immune system. Recent research indicates that its abnormal activation is one of the core drivers of neuroinflammation and is involved in the pathogenesis of various neurodegenerative diseases, including Parkinson's and Alzheimer's diseases. Although inhibiting NLRP3 holds significant therapeutic potential, no direct and specific NLRP3-targeting drug candidate has yet been approved, underscoring the urgent need for continued research and development in this field.
ISM8969 is a potential best-in-class NLRP3 inhibitor discovered and optimized through Insilico Medicine's proprietary generative chemistry engine, Chemistry42. In preclinical studies, this molecule has demonstrated outstanding efficacy, favorable safety, and significant anti-inflammatory activity across multiple disease models. Notably, ISM8969 exhibits ideal blood-brain barrier (BBB) penetration ability, enabling the candidate to cross the blood-brain barrier and potentially deliver therapeutic benefits for neuroinflammation-related diseases.
Based on promising preclinical data, Insilico Medicine has designated ISM8969 as the preclinical candidate for this project and has extensively evaluated the molecule in multiple neurological disease models.
