FDA Grants Fast Track Designation to Insilico’s AI-Designed Molecule ISM6331

FDA Grants Fast Track Designation to Insilico’s AI-Designed Molecule ISM6331

On July 29, the FDA granted Fast Track designation to Insilico Medicine’s ISM6331 for the treatment of unresectable malignant pleural mesothelioma following prior therapy. The designation allows more frequent discussions with the regulator about trial design, while the phase 1 study continues to enroll participants.

ISM6331 is intended for adults whose disease has progressed after anti-PD-1 therapy, with or without anti-CTLA-4 therapy, and platinum-based chemotherapy. An announcement from Insilico states that this is the first Fast Track designation for a program from the company’s AI drug development pipeline.

Fast Track changes how the team works with the FDA: the team will be able to discuss trial design, biomarkers, and the development plan more frequently, and to receive written feedback. Completed sections of the marketing application may also be submitted as they become ready under Rolling Review.

The ClinicalTrials.gov registry describes an international phase 1 study with a planned enrollment of 100 participants. Investigators are assessing which doses cause unacceptable toxicity, which adverse events occur, and which dose should be taken forward into phase 2. The drug is taken as a capsule once daily.

The company describes ISM6331 as an inhibitor of TEAD proteins associated with the Hippo signaling pathway, which is involved in cell division and survival. Using its Chemistry42 platform, Insilico generated molecular candidates based on the target’s structure and ranked them using its own scoring methods. The company selected ISM6331 for testing in humans through this process.

The phase 1 study is already underway, and Fast Track adds regular communication with the FDA. Insilico received the designation for a specific molecule that its system helped select for clinical testing.