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
Kymera Therapeutics (NASDAQ: KYMR) announced late-breaking presentations of positive Phase 1 results for KT-621, their first-in-class oral STAT6 degrader, at two major medical conferences. The Phase 1 healthy volunteer trial demonstrated that KT-621 achieved >90% STAT6 degradation in blood at doses above 1.5 mg and complete degradation in both blood and skin at doses ≥50 mg.
The drug showed impressive biomarker results comparable or superior to dupilumab, with TARC reduction up to 37% and Eotaxin-3 reduction up to 63%. KT-621's BroADen Phase 1b trial in atopic dermatitis patients will report data in Q4 2025, followed by Phase 2b trials in AD and asthma initiating in Q4 2025 and Q1 2026, respectively.
Kymera Therapeutics (NASDAQ: KYMR) ha annunciato durante le presentazioni a due importanti congressi medici i risultati positivi di Fase 1 per KT-621, il primo degrader orale di STAT6 di questa classe, in due filmati principali. Nel trial di Fase 1 su volontari sani, KT-621 ha raggiunto una degradazione di STAT6 superiore al 90% nel sangue a dosi superiori a 1,5 mg e una degradazione completa sia nel sangue sia nella pelle a dosi ≥50 mg.
Il farmaco ha mostrato biomarcatori molto promettenti, paragonabili o superiori a quelli di dupilumab, con una riduzione di TARC fino al 37% e una riduzione di Eotaxin-3 fino al 63%. Il trial BroADen di Fase 1b in pazienti affetti da dermatite atopica fornirà i dati nel Q4 2025, seguito dall’avvio di studi di Fase 2b in AD e in asma nel Q4 2025 e nel Q1 2026, rispettivamente.
Kymera Therapeutics (NASDAQ: KYMR) anunció durante dos importantes congresos médicos resultados positivos de la fase 1 para KT-621, su degradador oral de STAT6 de primera clase. En el ensayo de fase 1 en voluntarios sanos, KT-621 logró una degradación de STAT6 superior al 90% en sangre con dosis superiores a 1,5 mg y una degradación completa tanto en sangre como en piel con dosis ≥50 mg.
El fármaco mostró resultados de biomarcadores impresionantes, comparables o superiores a dupilumab, con una reducción de TARC de hasta el 37% y una reducción de Eotaxin-3 de hasta el 63%. El ensayo BroADen de Fase 1b en pacientes con dermatitis atópica reportará datos en el Q4 de 2025, seguido por ensayos de Fase 2b en AD y en asma que comenzarán en el Q4 de 2025 y en el Q1 de 2026, respectivamente.
Kymera Therapeutics (NASDAQ: KYMR)는 두 주요 의학 학회에서 KT-621의 1상 긍정적 결과를 발표했습니다. KT-621은 STAT6를 표적하는 경구용 최초의 디그레이더로, 건강한 자원자 대상 1상에서 STAT6의 혈중 90% 이상 분해를 1.5 mg 초과 용량에서 달성했고, 50 mg 이상 용량에서는 혈액과 피부에서 완전 분해를 관찰했습니다.
이 약물은 dupilumab과 비교해도 더 낫거나 동등한 바이오마커 결과를 보였으며, TARC가 최대 37% 감소, Eotaxin-3가 최대 63% 감소를 나타냈습니다. KT-621의 BroADen 1b 단계 연구는 피부염 환자에서 Q4 2025에 데이터를 발표하고, 이어 2025년 Q4 및 2026년 Q1에 각각 AD와 천식에서의 2b 단계 연구가 시작될 예정입니다.
Kymera Therapeutics (NASDAQ: KYMR) a annoncé lors de deux grandes conférences médicales des résultats positifs de la phase 1 pour KT-621, leur dégradateur oral de STAT6 de première classe. Dans l’essai de phase 1 chez des volontaires sains, KT-621 a atteint une dégradation de STAT6 > 90% dans le sang à des doses supérieures à 1,5 mg et une dégradation complète dans le sang et la peau à des doses ≥50 mg.
Le médicament a montré des résultats de biomarqueurs impressionnants comparables ou supérieurs à dupilumab, avec une réduction de TARC jusqu’à 37% et une réduction d’Eotaxin-3 jusqu’à 63%. L’essai BroADen de phase 1b chez des patients atteints de dermatite atopique rapportera les données au quatrième trimestre 2025, suivi par des essais de phase 2b en AD et en asthme prévus respectivement pour le quatrième trimestre 2025 et le premier trimestre 2026.
Kymera Therapeutics (NASDAQ: KYMR) kündigte auf zwei großen medizinischen Konferenzen beeindruckende Phase-1-Ergebnisse für KT-621 an, ihren erstklassigen oralen STAT6-Degrader. In einer Phase-1-Studie mit gesunden Freiwilligen erreichte KT-621 eine STAT6-Dekonstruktion >90% im Blut bei Dosen über 1,5 mg und eine vollständige Dekonstruktion im Blut und in der Haut bei Dosen ≥50 mg.
Das Medikament zeigte beeindruckende Biomarker-Ergebnisse, die mit Dupilumab vergleichbar oder überlegen waren, mit einer Reduktion von TARC bis zu 37% und einer Reduktion von Eotaxin-3 bis zu 63%. Die BroADen-Phase-1b-Studie bei atopischer Dermatitis wird Daten im Q4 2025 berichten, gefolgt von Phase-2b-Studien in AD und Asthma, die im Q4 2025 bzw. Q1 2026 beginnen sollen.
Kymera Therapeutics (NASDAQ: KYMR) أعلنت في وقت متأخر عن عروض تقديمية لنتائج المرحلة 1 الإيجابية لـ KT-621، مثبط STAT6 فموي من فئة أولى، في مؤتمرين طبيين بارزين. أظهر تجربة المرحلة 1 على متطوعين أصحاء أن KT-621 حقق تحلل STAT6 يتجاوز 90% في الدم عند جرعات أعلى من 1.5 ملغ، وتحلل كامل في الدم والجلد عند جرعات ≥50 ملغ.
أظهر الدواء نتائج بيوماركر ملحوظة، تقارن أو تفوق dupilumab، مع خفض TARC حتى 37% وخفض Eotaxin-3 حتى 63%. ستعرض تجربة BroADen للمرحلة 1b في مرضى الأكزيما التأتبية بياناتها في الربع الرابع من 2025، تليها تجارب المرحلة 2b في الأكزيما و الربو التي ستبدأ في الربع الرابع من 2025 وفي الربع الأول من 2026، على التوالي.
Kymera Therapeutics (NASDAQ: KYMR) 在两场重要医疗会议上宣布了 KT-621 的积极阶段 I 结果，这是他们首个同类口服 STAT6 分解剂。健康志愿者阶段 I 实验显示，KT-621 在剂量高于 1.5 mg 时可在血液中实现 STAT6>90% 的降解，在剂量 ≥50 mg 时在血液和皮肤中均实现完全降解。
该药物在生物标志物方面表现突出，达到与 dupilumab 相当甚至更优的水平，TARC 下降最高 37%，Eotaxin-3 下降最高 63%。BroADen Ib 期在特应性皮炎患者中的试验将在 2025 年第四季度公布数据，随后在 2025 年第四季度和 2026 年第一季度分别启动的 AD 和哮喘的 IIb 期试验。
- Strong Phase 1 results showing >90% STAT6 degradation in blood at doses above 1.5 mg
- Complete STAT6 degradation achieved in both blood and skin at MAD doses ≥50 mg
- Superior biomarker results compared to dupilumab with up to 37% TARC and 63% Eotaxin-3 reduction
- Well-tolerated safety profile undifferentiated from placebo
- Rapid advancement to Phase 2b trials in multiple indications
- Phase 1b trial results still pending, creating uncertainty about efficacy in actual patients
- Competition from established treatments like dupilumab in target indications
Insights
Kymera's oral STAT6 degrader KT-621 shows promising Phase 1 results with dupilumab-like effects and clear development timeline.
Kymera's announcement of positive Phase 1 data for KT-621 represents a potentially significant advancement in immunological disease treatment. The data reveals that this first-in-class oral STAT6 degrader achieved >90% STAT6 degradation at doses above 1.5mg, with complete degradation in both blood and skin at multiple ascending doses ≥50mg. The mechanism directly targets the STAT6 transcription factor in the Th2 inflammatory pathway - the same pathway targeted by approved biologics like
The biomarker data is particularly compelling, showing
The clinical development plan is progressing rapidly with multiple value-creating catalysts ahead: Phase 1b data in atopic dermatitis expected in Q4 2025, Phase 2b trial initiation in atopic dermatitis in Q4 2025, and Phase 2b in asthma starting in Q1 2026. Kymera's strategy to pursue parallel development across multiple Th2-driven indications (dermatology, gastroenterology, respiratory) follows the successful playbook of biologics like dupilumab, but with the significant advantage of oral administration.
The scientific validation through late-breaking presentations at two prestigious European congresses (EADV and ERS) provides external credibility to these findings. The preclinical data showing KT-621's effect on AD-relevant genes in keratinocytes similar to dupilumab further supports the biological rationale. If successful in later-stage trials, KT-621 could represent a paradigm shift as the first oral alternative to injectable biologics for multiple immunological conditions driven by Th2 inflammation.
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, >
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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