On June 2, Kymera Therapeutics Inc. (NASDAQ:
KYMR
) announced positive first-in-human results from its Phase 1 healthy volunteer clinical trial of KT-621, which is a first-in-class, oral STAT6 degrader. The study demonstrated that once-daily KT-621 surpassed Kymera’s target product profile, which shows significant de-risking for the program due to its oral and biologics-like efficacy and safety.
A biopharmaceutical laboratory with scientists in lab coats working on medicines.
The trial was a double-blind and placebo-controlled study that enrolled 118 healthy subjects across single ascending dose/SAD and multiple ascending dose/MAD cohorts. It aimed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics, such as STAT6 protein levels and Th2 biomarkers. SAD cohorts, which ranged from 6.25 to 800 mg, included 48 participants, while MAD cohorts, administered once daily for 14 days at doses from 1.5 to 200 mg, included 70 participants.
KT-621 achieved remarkable STAT6 degradation: over 90% mean STAT6 degradation in blood was observed at all doses above 1.5 mg, and complete STAT6 degradation in both blood and skin was achieved at all MAD doses of 50 mg or greater. KT-621 also showed a positive impact on Th2 biomarkers. The safety profile of KT-621 was undifferentiated from placebo, with no severe adverse events, and no treatment-related adverse events in more than one subject across all dose levels up to 200 mg.
Kymera Therapeutics Inc. (NASDAQ:KYMR) is a clinical-stage biopharmaceutical company that discovers and develops small-molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body’s own natural protein degradation system.
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Disclosure: None. This article is originally published at
Insider Monkey
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