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. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance for the treatment of mesothelioma, following the grant of Orphan Drug Designation (ODD) in June 2024.
It brings the total number of IND-approved molecules of Insilico to nine. Mesothelioma is a type of cancer that affects the mesothelium, a thin layer of tissue that covers most of the internal organs, primarily caused by exposure to asbestos. As an aggressive and fatal disease, Mesothelioma tends to spread along surfaces, nerves, and blood vessels inside the body, the median survival of the disease after diagnosis is only 9 to 12 months.
Traditional treatments, including surgery and radiotherapy, often fail to provide long-term benefits, highlighting the urgent need for innovative treatment options. 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.
We will move forward with patient enrollment in the US as soon as possible and look forward to advancing ISM6331 for patients in high unmet medical needs with mesothelioma and other Hippo pat.