Third Harmonic says IND-enabling toxicology studies of THB335 nearing completion

Third Harmonic Bio also provided a business update on its lead program, THB335, a potent, highly selective oral small molecule KIT inhibitor in development for the treatment of chronic spontaneous urticaria and other mast-cell mediated inflammatory disorders. IND-enabling toxicology studies of THB335 are nearing completion, and the company recently completed its pre-IND written correspondence with the U.S. FDA. The company is on track to file a U.S. IND and initiate a Phase 1 SAD/14-day MAD study of THB335 during the first half of 2024. The company maintains a strong financial position with cash and cash equivalents totaling $273.9 million as of September 30, 2023.