Intensity Therapeutics, Inc. (INTS) issued a business update on its phase 3 sarcoma clinical program. In the fourth quarter, the company submitted a new IND to the FDA which included the phase 3 protocol for a superiority trial of the 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 a "Study May Proceed" letter for phase 3. The company is working with contracted vendors to initiate the phase 3 trial in the first half of 2024.
Also, during the fourth quarter, the company was granted a meeting that was held with the FDA to review the INT230-6 chemical manufacturing and controls or CMC for INT230-6. The company and FDA agreed upon a plan for the CMC set of activities for the active pharmaceutical ingredients and the drug product, INT230-6, necessary for the NDA.
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