"The consistency we've demonstrated across KT-621 Phase 1 studies, from robust STAT6 degradation to a favorable safety profile, reflects the strong fidelity of translation of this unique approach from preclinical to clinical settings and further highlights KT-621's compelling profile," said Jared Gollob, MD, Chief Medical Officer of Kymera Therapeutics. "We believe KT-621 has the potential to transform care through a truly novel oral treatment option for patients living with chronic Type 2 inflammatory conditions, and the data reported to date continue to support its advancement globally across multiple diseases, starting with atopic dermatitis and asthma."
The Company has previously reported positive Phase 1 data for KT-621 in non-Japanese healthy volunteers and patients with moderate to severe atopic dermatitis. Across these studies, KT-621 demonstrated rapid, deep and sustained STAT6 degradation in blood and skin, robust reductions in disease-relevant Type 2 inflammatory biomarkers, meaningful improvements on clinical endpoints and patient-reported outcomes in atopic dermatitis as well as in comorbid asthma and allergic rhinitis, and a favorable safety profile.
The Phase 1 trial in healthy Japanese adults was designed to provide the pharmacokinetic/pharmacodynamic (PK/PD) and safety data required by regulators prior to enrollment of patients in Japan in the global KT-621 Phase 2b studies. The randomized, double-blind, placebo-controlled Phase 1 study enrolled 24 healthy Japanese adults across two dose levels randomized 3:1 to receive KT-621 or placebo once daily for seven days. KT-621 demonstrated a favorable PK profile, including rapid absorption and dose-proportional increases in plasma exposure, and rapid, sustained STAT6 degradation in blood, with median degradation ≥98% at both dose levels at Day 7. KT-621 was well tolerated with a favorable safety profile across both doses. Overall, these results in healthy Japanese adults were comparable to those observed in non-Japanese adults and atopic dermatitis patients, further supporting KT-621's potential as a novel oral approach for chronic Type 2 inflammatory diseases.
The parallel KT-621 Phase 2b trials in atopic dermatitis and asthma are ongoing, with data expected by mid-2027 and late 2027, respectively. These studies are intended to accelerate KT-621 development for subsequent parallel Phase 3 registration studies across multiple Type 2 inflammatory diseases.
Japanese Dermatological Association (JDA) Annual Meeting
- Title: KT-621, an Oral, Once Daily STAT6 Degrader: PK, PD and Safety in Healthy Japanese Adults
- Type/Session: Oral Presentation, Inflammatory Disease
- Speaker: Sagar Agarwal, PhD, Vice President, Clinical Pharmacology, Kymera Therapeutics
- Date/Time: Friday, June 12, 2026, at 10:10 am JST
A copy of the JDA presentation will be available in the Resource Library section of Kymera's website.
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