Benzinga -
- Third Harmonic Bio Inc (NASDAQ: THRD) will discontinue the ongoing Phase 1b study of THB001 in chronic inducible urticaria, after observing asymptomatic liver transaminitis in two subjects enrolled in the first dose cohort of 200mg BID.
- Chronic inducible urticaria is a common inflammatory skin condition characterized by the recurrence of itchy wheals and/or angioedema.
- The company is initiating nonclinical studies to elucidate the mechanism for the observed transaminitis, which was not predicted by extensive GLP toxicology studies of THB001 nor observed in the company's Phase 1a study.
- In parallel with the early clinical development of THB001, the company has conducted an extensive medicinal chemistry effort to identify chemically distinct next-generation oral wild-type KIT inhibitors and has advanced multiple candidate molecules into exploratory toxicology studies.
- The company intends to nominate a development candidate from this program in 2023.
- Preliminary analyses show evidence of pharmacodynamic and clinical activity at the 200mg BID dose.
- The company plans to present the full data set from the five enrolled subjects at an upcoming scientific conference and to provide an update on overall corporate strategy and outlook in early 2023.
- Price Action: THRD shares are down 75.50% at $4.86 on the last check Thursday.