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Intensity Therapeutics Announced A Business Update Reflecting Progress In Its Phase 3 Sarcoma Clinical Program; FDA Provided "Study May Proceed Letter" For Phase 3 Within 30 Day Period Following IND Submission

Benzinga ·  Jan 3 08:08

IND Submission for Phase 3

In the fourth quarter of 2023, the Company submitted a new Investigational New Drug ("IND") to the Food and Drug Administration ("FDA"). The submission included the phase 3 protocol for a superiority trial of the Company's lead product INT230-6 used as monotherapy compared to the standard of care drugs in 2nd and 3rd line treatment for certain soft tissue sarcoma subtypes. The FDA provided the Company a "Study May Proceed" letter for phase 3 within the 30 day period following the IND submission. The study is an open-label, randomized phase 3 trial expected to enroll 333 patients. For every three patients enrolled, two...

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