Updated THB335 Phase 1 Clinical Data and Phase 2 Readiness Activities (GlobeNewswire) - Jun 12, 2025 - P1 | N=56 | NCT06425861 | Sponsor: Third Harmonic Bio, Inc. | "The 100mg QD dose showed pharmacokinetics and pharmacodynamics largely consistent with the 164mg dose level evaluated in a prior MAD cohort of the Phase 1 clinical trial, with mean plasma trough exposures exceeding the 90% inhibition concentration (IC90) of KIT by over six-fold, and an 85% mean reduction from baseline of serum tryptase, a biomarker of mast cell activation....The Company has now completed all clinical, toxicology and manufacturing activities to support a Phase 2 clinical trial of THB335 for the treatment of chronic spontaneous urticaria, and it plans to submit imminently a regulatory filing with the US Food and Drug Administration (FDA) to seek clearance for trial initiation."
New P2 trial • P1 data • Chronic Spontaneous Urticaria
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