Kymera Therapeutics Announces Late-Breaking Oral Presentations on KT-621, a First-In-Class, Oral STAT6 Degrader, at the European Academy of Dermatology & Venereology and European Respiratory Society Congresses
Featured presentations showcase the positive Phase 1 healthy volunteer trial results supporting KT-621’s oral, dupilumab-like profile
KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients on track to report data in 4Q25
KT-621 Phase 2b trials in AD and asthma on track to initiate in 4Q25 and 1Q26, respectively
WATERTOWN, Mass., Sept. 17, 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 the positive results from the Phase 1 healthy volunteer clinical trial of KT-621, its first-in-class, oral STAT6 degrader, will be featured in two separate late-breaking oral presentations at the European Academy of Dermatology & Venereology (EADV) Congress being held September 17-20, in Paris, France, and at the European Respiratory Society (ERS) Congress being held September 27-October 1, in Amsterdam, Netherlands. Additionally, the Company will share new preclinical data in an EADV poster that builds upon KT-621’s compelling characterization in disease-relevant contexts compared to dupilumab.
“These featured presentations highlight the opportunity for KT-621 to expand patient access to a novel oral systemic advanced therapy in many common immuno-inflammatory diseases, such as atopic dermatitis and asthma, that have limited or suboptimal treatment options,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “KT-621’s impressive and consistent data highlighting robust target and pathway engagement, show the revolutionary potential of STAT6 degradation to phenocopy the activity of upstream biologics, like dupilumab, while offering the convenience of a once daily oral medicine. We’re continuing to rapidly advance this program and are on track to share the BroADen Phase 1b AD study data, and to initiate our first Phase 2b study in AD, both in the fourth quarter of this year.”
In the Phase 1 healthy volunteer single- and multiple-ascending dose (SAD/MAD) study presented at EADV and ERS, KT-621 demonstrated rapid, deep and prolonged STAT6 degradation in blood and skin. In blood, >90% mean STAT6 degradation was achieved at all doses above 1.5 mg. Complete STAT6 degradation was achieved in both blood and skin at all MAD doses ≥50 mg. KT-621 demonstrated an impact on disease-relevant Th2 biomarkers in line with or superior to dupilumab, with median TARC reduction up to 37% and median Eotaxin-3 reduction up to 63%. KT-621 was well-tolerated with a safety profile undifferentiated from placebo.
In a preclinical poster presented at EADV, new data show that KT-621 modulated AD-relevant genes in IL-4-stimulated keratinocytes similar to dupilumab. Keratinocytes are key skin cells involved in the disease pathology of AD through epidermal barrier dysregulation. These findings further support the relevance of the STAT6 pathway in Th2 inflammation driving skin diseases, and the potential of KT-621 to fully block Th2 signaling by effectively targeting and degrading STAT6.
The KT-621 BroADen Phase 1b trial, an open label study in patients with moderate to severe AD, is ongoing, with data expected to be reported in the fourth quarter of 2025. Two parallel Phase 2b studies in AD and asthma patients are planned to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively. The Phase 2b studies are expected to accelerate KT-621 development for subsequent parallel Phase 3 registration studies across multiple Th2 dermatology, gastroenterology and respiratory indications.
European Academy of Dermatology & Venereology (EADV) 2025 Congress
Title: KT-621, an Oral, Once Daily, Targeted STAT6 Degrader: First-in-Human Phase 1a Safety, Pharmacokinetics, Pharmacodynamics and Th2 Biomarker Effects
Presentation ID: D1T01.2F
Type/Session: Oral Presentation, Late Breaking News
Speaker: Mahta Mortezavi, MD, Senior Medical Director, Clinical Development
Date/Time: Wednesday, September 17, 2025, 5:15-5:30 PM CET
Title: The Potent and Selective Oral STAT6 Degrader, KT-621, Affects Gene Transcripts in Human Keratinocytes as Effectively as Dupilumab, and Blocks Th2 Inflammation in Atopic Dermatitis and Asthma Mouse Models
Poster ID: P3278
Type/Session: ePoster, Atopic Dermatitis/Eczema – Part II
European Respiratory Society (ERS) 2025 Congress
Title: Safety, Pharmacokinetics and Pharmacodynamics of KT-621, an Oral STAT6 Degrader, in Healthy Adults
Presentation ID: OA3288
Type/Session: Oral Presentation, Late Breaking Abstract
Speaker: Arsalan Shabbir, MD, PhD, Vice President, Clinical Development
Date/Time: Monday, September 29, 2025, 9:30 – 9:35 AM CET
Copies of the EADV and ERS presentations will be available in the Resource Library section of Kymera's website after the sessions.
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 Th2 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 Th2 biomarkers, and a safety profile undifferentiated from placebo. KT-621, the first STAT6-directed medicine 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 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.
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 KT-621, the Phase 1b data readout of KT-621 in AD patients in the fourth quarter of 2025, the initiation of Phase 2b studies of KT-621 in patients with AD and asthma in the fourth quarter of 2025 and first quarter of 2026, respectively, the effect of initial parallel development of Phase 2b studies in AD and asthma patients on acceleration of late parallel development across multiple indications, and the preliminary cross-study assessments comparing non-head-to-head clinical data of KT-621 to published data for dupilumab. 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, risks associated with: the risk that cross-trial comparisons may not be reliable as no head-to-head trials have been conducted comparing KT-621 to dupilumab, and Phase 1 clinical data for KT-621 may not be directly comparable to dupilumab’s clinical data due to differences in molecule composition, trial protocols, dosing regimens, and patient populations and characteristics, 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 1 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. 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.
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