Third Harmonic Bio reports updated THB335 data, initiates THB335 sale

As part of the previously announced ongoing Phase 2 readiness activities, the Company recently completed an additional 14-day multiple ascending dose cohort in the Phase 1 clinical trial of THB335 in healthy volunteers. The cohort evaluated the pharmacokinetics, pharmacodynamics and safety of THB335 at a once-daily dose of 100mg utilizing a new drug product capsule formulation that is intended for use in future clinical development. 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 of KIT by over six-fold, and an 85% mean reduction from baseline of serum tryptase, a biomarker of mast cell activation. All adverse events were mild, with the exception of one moderate adverse event of neutrophil reduction. There were no adverse events due to hemoglobin reduction, nor any other clinically significant laboratory value changes reported in the cohort. One subject experienced mild hair color change and mild taste loss, which resolved during the follow-up period. 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 to seek clearance for trial initiation. The Company also announced it is initiating a sale process of THB335 and related intellectual property.