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Third Harmonic Bio, Inc. (Nasdaq: THRD) is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for severe allergy and inflammation. The cornerstone of their research is the KIT inhibitor, a cell surface receptor that regulates mast cells, which play a crucial role in allergic and inflammatory responses.
The company’s lead product candidate, THB001, marked a significant milestone as the first highly selective, oral small-molecule KIT inhibitor to enter clinical development. Despite early termination of its Phase 1b clinical trial due to observed liver toxicity in a limited number of patients, THB001 demonstrated promising clinical benefits in treating chronic inducible urticaria, a condition characterized by chronic, often painful hives.
Building on the insights from THB001, Third Harmonic Bio is now advancing THB335, a next-generation KIT inhibitor with structural modifications aimed at mitigating the hepatotoxicity risks observed in its predecessor. THB335 retains the potency and selectivity of THB001 and is anticipated to offer a safer metabolic profile. The company has planned to initiate clinical trials of THB335 in the first half of 2024, focusing initially on chronic spontaneous urticaria with potential expansion to other mast cell-mediated inflammatory disorders.
Third Harmonic Bio's innovative approach extends to a broad range of dermatologic, respiratory, and gastrointestinal diseases. By focusing on highly selective, oral small-molecule inhibitors, the company aims to provide effective, easy-to-administer treatments that could revolutionize care for patients with mast cell-mediated inflammatory conditions.
Financially, the company is robust with $273.9 million in cash and cash equivalents as of September 30, 2023, sufficient to fund operations through at least 2025. Recent corporate achievements include the FDA clearance of their IND application for THB335 and the initiation of a Phase 1 clinical trial in healthy volunteers.
The executive team, led by CEO Natalie Holles, has been strengthened with key appointments, including a new Chief Scientific Officer, Chief Non-Clinical Development Officer, and Chief Development Operations Officer, each bringing extensive experience in drug discovery and development.
For more information, please visit the Third Harmonic Bio website: www.thirdharmonicbio.com.
Third Harmonic Bio (THRD) reported its financial results for the fourth quarter and full year ended December 31, 2022. The company has a robust cash position of $288.9 million, sufficient to support operations for at least the next twelve months. Research and development expenses rose to $9.3 million in Q4 2022, up from $4.3 million in Q4 2021, and full-year R&D expenses increased to $24.4 million, compared to $15.7 million in 2021. Although the company achieved a decrease in net loss to $11.5 million for Q4 2022, the full-year net loss was $35.2 million, up from $29.6 million in 2021. The company is progressing towards selecting a next-generation KIT inhibitor candidate.
Third Harmonic Bio (THRD) announced the discontinuation of its Phase 1b study of THB001 due to asymptomatic liver transaminitis observed in two subjects at the 200mg BID dose. Although disappointing, preliminary analyses indicate clinical activity at this dose. The company is prioritizing patient safety and will conduct nonclinical studies to investigate the liver effects. In 2023, THRD aims to nominate a new development candidate from its next-generation oral wild-type KIT inhibitors.
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