Insilico Medicine ('Insilico'), a clinical-stage generative artificial intelligence (AI)-driven biotechnology company, today announced ISM6331, potential best-in-class pan-TEAD inhibitor, has received the U.S.
InSilico Medicine Aug 8 2024 Insilico Medicine , a clinical-stage generative artificial intelligence -driven biotechnology company, today announced ISM6331, potential best-in-class pan-TEAD inhibitor, has received the U.S. Food and Drug Administration Investigational New Drug clearance for the treatment of mesothelioma, following the grant of Orphan Drug Designation in June 2024. It brings the total number of IND-approved molecules of Insilico to nine.
We are thrilled to receive the FDA's ODD designation and approval to initiate clinical evaluation of ISM6331. The preclinical development of ISM6331 not only demonstrates the AI-driven approach to innovative drug discovery and development, but also showcases the best-in-class capabilities of Insilico's R&D team.
In preclinical studies, ISM6331 shows broad anti-tumor effect in multiple cell lines and potent efficacy at low doses in animal models, as well as a high safety margin and favorable ADMET profiles. The promising data further motivated Insilico to nominate ISM6331 as a preclinical candidate for the program in June 2023. Insilico is committed to advancing the clinical translation of the program and accelerating the delivery of to meet unmet medical needs.
Previously, ISM6331 was granted Orphan Drug Designation by the FDA for the treatment of mesothelioma. The designation would qualify ISM6331 for certain benefits and incentives, including seven years of marketing exclusivity following the regulatory approval of the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees.
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