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.
About Third Harmonic Bio, Inc.
Third Harmonic Bio is a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases through the development of novel highly selective, small-molecule inhibitors of KIT, a cell surface receptor that serves as the master regulator of mast cell function and survival. Early clinical studies demonstrate that KIT inhibition has the potential to revolutionize the treatment of a broad range of mast-cell-mediated inflammatory diseases, and that a titratable, oral, intracellular small molecule inhibitor may provide the optimal therapeutic profile against this target. Third Harmonic Bio’s lead product candidate, THB335, is a titratable, oral, intracellular small molecule inhibitor expected to enter clinical trials during the first half of 2024. For more information, please visit the Third Harmonic Bio website: www.thirdharmonicbio.com.
Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, the roles and responsibilities of Chris Murphy, the timing of Third Harmonic Bio completing IND-enabling studies of THB335, the filing a U.S. IND application for THB335, and the expected timing for clinical activities. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to Third Harmonic Bio’s cash forecasts, ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, our ability to protect our intellectual property, the timing and results of preclinical and clinical trials, changes to laws or regulations, market conditions, geopolitical events, and further impacts of pandemics or health epidemics, that could cause actual results to differ materially from what Third Harmonic Bio expects. Further information on potential risk factors that could affect Third Harmonic Bio’s business and its financial results are