Kymera Therapeutics Announces First Patient Dosed in BROADEN2 Phase 2b Atopic Dermatitis Clinical Trial of a First-in-Class, Oral STAT6 Degrader
Kymera Therapeutics, Inc. recently announced it recently initiated dosing in its BROADEN2 Phase 2b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD). The Company expects to report data from the BROADEN2 trial by mid-2027. Additionally, the Company previously announced it completed dosing in the KT-621 BroADen Phase 1b trial in AD, with data to be reported in December 2025.
“The initiation of dosing in the BROADEN2 trial represents a major step in the advancement of our first-in-industry STAT6 degrader program and reflects the continued progress of our translational strategy, building a robust foundation for future development across multiple Type 2 diseases,” Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “With additional key clinical milestones on the horizon – including the BroADen Phase 1b data in December and BREADTH Phase 2b asthma trial launch in the first quarter of 2026 – we remain focused on realizing the promise of KT-621 as a potential first-in-class oral treatment option for millions of patients living with chronic immunological diseases.”
The KT-621 BROADEN2 Phase 2b trial is a randomized, double-blind, placebo-controlled, multicenter, dose-ranging study evaluating the efficacy, safety and tolerability of three doses of KT-621 in approximately 200 patients with moderate to severe AD over 16 weeks. Baseline eligibility criteria include an Eczema Area and Severity Index (EASI) score of at least 16, at least 10% of body surface area affected, and an average weekly Pruritis Numerical Rating Scale (NRS) score of at least 4. Patients from the study have the opportunity to participate in a 52-week open label extension period after completion of the trial. The primary endpoint is the percent change from baseline in EASI score at Week 16. Secondary endpoints will evaluate a range of additional safety and efficacy measures, including the proportion of patients achieving EASI-50, EASI-75, a validated Investigator Global Assessment (vIGA) score of 0 to 1, and at least a 4-point improvement in Peak Pruritus NRS. More information on the BROADEN2 study can be found on clinicaltrials.gov (NCT07217015).
The Company is on track to initiate BREADTH, a Phase 2b trial in moderate to severe asthma patients, in the first quarter of 2026. The parallel Phase 2b studies in AD and asthma are expected to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registrational studies across multiple Type 2 dermatology, gastroenterology and respiratory indications.
KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation. In the Phase 1 clinical study in healthy volunteers, KT-621 demonstrated complete STAT6 degradation in blood and skin following low daily oral doses, reductions of multiple disease relevant Type 2 biomarkers, and a safety profile undifferentiated from placebo. KT-621, the first STAT6-directed drug to enter clinical evaluation, has the potential to transform treatment paradigms for more than 130 million patients around the world, including children and adults, suffering from Type 2 diseases such as atopic dermatitis (AD), asthma, bullous pemphigoid (BP), chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others.
Atopic dermatitis (AD) is the most common form of eczema, a chronic inflammatory disease that causes the skin to become inflamed and irritated, making it extremely pruritic (itchy). AD occurs most frequently in children but also affects adults. It can affect a patient’s quality of life and lead to additional complications, such as infections and sleep loss. While there are currently available medicines for AD, such as topical therapies and injectable biologics, there remains a significant unmet need and opportunity to improve treatment options for millions of patients. Learn more about AD on Kymera’s website.
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.
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