Data from the KT-621 BROADEN2 Phase 2b AD patient trial expected to be reported by mid-2027
KT-621 BREADTH Phase 2b trial in asthma on track to initiate in 1Q26
Completed dosing in KT-621 BroADen Phase 1b AD trial with data to be reported in December 2025
WATERTOWN, Mass., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that 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.
About KT-621
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.
About Atopic Dermatitis
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.
About Kymera Therapeutics
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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, including for the Phase 1b data readout of KT-621 in AD patients in December 2025, the Phase 2b data readout of KT-621 in AD patients by mid-2027 and the initiation of Phase 2b studies of KT-621 in patients with asthma in the first quarter of 2026. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," "upcoming" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, that the results from the Phase 1b KT-621 trial may differ from the Phase 1a KT-621 data, that preclinical and clinical data, including the results from the Phase 1a trial of KT-621, is not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidate, uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with and submissions to regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements, the unexpected emergence of adverse events or other undesirable side effects during preclinical and clinical development, whether Kymera will be able to fund development activities and achieve development goals, and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor and Media Contact:
Justine Koenigsberg
Vice President, Investor Relations
investors@kymeratx.com
media@kymeratx.com
857-285-5300
