Kymera Therapeutics Announces First Patient Dosed in BROADEN Phase 1b Atopic Dermatitis Clinical Trial of First-in-Class Oral STAT6 Degrader

Kymera Therapeutics, Inc. recently announced it recently initiated dosing in its BroADen Phase 1b 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 BroADen trial in the fourth quarter of 2025. Additionally, the Company has completed SAD/MAD dosing and follow-up in the KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025.

“The advancement of KT-621 in patients with AD is an important step in the development of this exciting program and underscores the potential of our unique technology to revolutionize the treatment of complex immuno-inflammatory diseases through oral medicines with biologics-like profiles,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “As the first STAT6-targeted agent in clinical development, we believe KT-621 has the opportunity to dramatically alleviate the burden of disease for those suffering from AD by offering an effective and convenient oral medicine, and we look forward to advancing the clinical program and sharing updates throughout the year.”

The BroADen single-arm, open label Phase 1b trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in approximately 20 adult patients with moderate to severe AD. Patients will be administered KT-621 once daily for 28 days. The key study objective is to show that robust STAT6 degradation in blood and skin by KT-621 has a dupilumab-like effect on reducing multiple Th2 biomarkers in the blood and on the transcriptome of active AD skin lesions. The study will also assess effects on clinical endpoints such as Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS).

Two parallel Phase 2b clinical trials in moderate to severe AD and asthma patients are expected to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registration studies across multiple Th2 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 Th2 inflammation. STAT6 degradation has the potential to provide the convenience of an oral medicine with the potential for biologics-like activity and in doing so reach broader patient populations compared to injectable biologics or other standards of care. In preclinical studies, KT-621 demonstrated dupilumab-like activity in several in vitro and in vivo models and was safe and well tolerated. KT-621, the first STAT6 directed medicine to enter clinical evaluation, has the opportunity to transform treatment paradigms for more than 130 million patients around the world, including children and adults, suffering from Th2 diseases such as AD, asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others.

More information on the KT-621 BroADen trial in AD will be available on www.clinicaltrials.gov.

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.

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, visit www.kymeratx.com.