Third Harmonic Bio, Inc. (THRD), a clinical-stage biopharmaceutical company, on Tuesday announced promising results from its Phase 1 clinical trial of THB335, a potent and selective oral small molecule inhibitor of KIT, for chronic spontaneous urticaria or CSU.
The study, which included single and multiple ascending doses or SAD/MAD in healthy volunteers, demonstrated that THB335 was well-tolerated with dose-dependent reductions in serum tryptase, a biomarker of mast cell activation.
The Phase 1 results support the progression of THB335 into Phase 2 clinical trials for CSU, with reductions in tryptase levels believed to provide clinical benefit.
The compound also showed a half-life of approximately 40 hours, allowing for once-daily dosing.
Third Harmonic Bio is initiating a strategic review process to maximize shareholder value, considering potential strategic transactions and business combinations.
The company plans to begin its Phase 2 trial of THB335 in CSU by mid-2025.
Cash position:
As of December 31, 2024, the Company had approximately $285 million in cash and cash equivalents (unaudited).
The Company estimates it will have cash and cash equivalents in a range of approximately $262 million to $267 million on June 30, 2025.
THRD closed Monday's (Feb.10 2025) trading at $4.65 down 4.12%. In premarket trading Tuesday, the stock is down by 27.98% at $3.34.
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