Kymera initiates dosing in KT-621 Phase IIb atopic dermatitis trial

WorldPharmaceuticals
2025.11.27 10:51
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Kymera Therapeutics has started dosing in its BROADEN2 Phase IIb clinical trial for the oral STAT6 degrader, KT-621, in moderate to severe atopic dermatitis patients. The trial involves around 200 patients and aims to assess the safety, efficacy, and tolerability of KT-621 over 16 weeks. Primary and secondary endpoints include changes in EASI scores and pruritus improvement. Data is expected by mid-2027. The company also plans to launch a Phase IIb asthma trial in early 2026.

The placebo-controlled, randomised, double-blind includes approximately 200 patients. Credit: Kwangmoozaa / Shutterstock.com.

Kymera Therapeutics has commenced dosing in its BROADEN2 Phase IIb clinical trial assessing oral signal transducer and activator of transcription 6 (STAT6) degrader, KT-621, in moderate to severe atopic dermatitis (AD) patients.

The company anticipates reporting data by mid-2027.

The placebo-controlled, randomised, double-blind, multi-centre, dose-ranging BROADEN2 trial is designed to assess the safety, efficacy and tolerability of three doses of KT-621 in nearly 200 patients for over 16 weeks.

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Participants eligible for the study must have a minimum of 16 Eczema Area and Severity Index (EASI) score, at least 10% body surface area affected, and an average weekly pruritus numerical rating scale score of at least four.

The trial’s primary endpoint assesses the percent change in the EASI score from baseline at week 16.

Secondary endpoints include the proportions of patients achieving EASI-50, EASI-75, and an improvement of at least four points in Peak Pruritus NRS.

An open-label extension spanning 52 weeks follows the main study period.

Kymera Therapeutics chief medical officer Jared Gollob said: “The initiation of dosing in the BROADEN2 trial represents a major step in the advancement of our first-in-industry STAT6 degrader programme and reflects the continued progress of our translational strategy, building a robust foundation for future development across multiple type 2 diseases.”

“With additional key clinical milestones on the horizon – including the BroADen Phase Ib data in December and BREADTH Phase IIb asthma trial launch in the first quarter of 2026 – we remain focused on realising the promise of KT-621 as a potential first-in-class oral treatment option for millions of patients living with chronic immunological diseases.”

The company also concluded dosing in the KT-621 BroADen Phase Ib trial in subjects with AD, with results set to be presented in December 2025.

Kymera intends to initiate the BREADTH Phase IIb trial for moderate to severe asthma in the first quarter of 2026.

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