Kymera Therapeutics Announces First Patient Dosed in BROADEN Phase 1b Atopic Dermatitis Clinical Trial of KT-621, a First-in-Class Oral STAT6 Degrader
Kymera Therapeutics (NASDAQ: KYMR) has initiated dosing in its BroADen Phase 1b clinical trial for KT-621, a first-in-class oral STAT6 degrader, targeting moderate to severe atopic dermatitis (AD). The trial will evaluate approximately 20 adult patients with once-daily dosing for 28 days, focusing on safety, tolerability, and clinical activity.
The company has completed SAD/MAD dosing in the Phase 1 healthy volunteer trial, with data expected in June 2025. The BroADen trial results are anticipated in Q4 2025. Additionally, Kymera plans to launch two parallel Phase 2b trials: one for AD in Q4 2025 and another for asthma in Q1 2026.
The BroADen study aims to demonstrate that STAT6 degradation in blood and skin by KT-621 produces effects similar to dupilumab in reducing Th2 biomarkers. The trial will assess clinical endpoints including Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS).
Kymera Therapeutics (NASDAQ: KYMR) ha iniziato la somministrazione nel suo studio clinico di Fase 1b BroADen per KT-621, un degradatore orale di STAT6 di prima classe, indirizzato alla dermatite atopica (AD) da moderata a grave. Lo studio coinvolgerà circa 20 pazienti adulti con somministrazione giornaliera per 28 giorni, concentrandosi su sicurezza, tollerabilità e attività clinica.
L'azienda ha completato la somministrazione SAD/MAD nello studio di Fase 1 su volontari sani, con dati attesi per giugno 2025. I risultati dello studio BroADen sono previsti per il quarto trimestre 2025. Inoltre, Kymera prevede di avviare due studi paralleli di Fase 2b: uno per AD nel quarto trimestre 2025 e un altro per l'asma nel primo trimestre 2026.
Lo studio BroADen mira a dimostrare che la degradazione di STAT6 nel sangue e nella pelle da parte di KT-621 produce effetti simili a dupilumab nella riduzione dei biomarcatori Th2. Lo studio valuterà endpoint clinici quali l'Eczema Area and Severity Index (EASI) e la scala numerica del prurito (NRS).
Kymera Therapeutics (NASDAQ: KYMR) ha iniciado la dosificación en su ensayo clínico de Fase 1b BroADen para KT-621, un degradador oral de STAT6 de primera clase, dirigido a la dermatitis atópica (AD) moderada a grave. El ensayo evaluará aproximadamente a 20 pacientes adultos con una dosis diaria durante 28 días, enfocándose en la seguridad, tolerabilidad y actividad clínica.
La compañía ha completado la dosificación SAD/MAD en el ensayo de Fase 1 con voluntarios sanos, con datos esperados para junio de 2025. Se anticipan los resultados del ensayo BroADen para el cuarto trimestre de 2025. Además, Kymera planea lanzar dos ensayos paralelos de Fase 2b: uno para AD en el cuarto trimestre de 2025 y otro para asma en el primer trimestre de 2026.
El estudio BroADen tiene como objetivo demostrar que la degradación de STAT6 en sangre y piel por KT-621 produce efectos similares a dupilumab en la reducción de biomarcadores Th2. El ensayo evaluará puntos finales clínicos, incluyendo el Índice de Área y Severidad del Eccema (EASI) y la escala numérica de prurito (NRS).
Kymera Therapeutics (NASDAQ: KYMR)는 중등도에서 중증 아토피 피부염(AD)을 대상으로 하는 최초의 경구용 STAT6 분해제인 KT-621의 BroADen 1b상 임상시험에서 투약을 시작했습니다. 이 임상시험은 약 20명의 성인 환자를 대상으로 하루 1회 28일간 투여하며, 안전성, 내약성 및 임상 활동성을 평가합니다.
회사는 건강한 자원자를 대상으로 한 1상 SAD/MAD 투약을 완료했으며, 데이터는 2025년 6월에 발표될 예정입니다. BroADen 임상시험 결과는 2025년 4분기에 기대됩니다. 또한 Kymera는 2025년 4분기에 아토피 피부염을 위한 2b상 임상시험과 2026년 1분기에 천식을 위한 2b상 임상시험 두 건을 병행하여 시작할 계획입니다.
BroADen 연구는 KT-621에 의한 혈액 및 피부 내 STAT6 분해가 Th2 바이오마커 감소에 있어 두필루맙과 유사한 효과를 나타내는지를 입증하는 것을 목표로 합니다. 임상 평가지표로는 습진 부위 및 중증도 지수(EASI)와 가려움증 수치 평가척도(NRS)가 포함됩니다.
Kymera Therapeutics (NASDAQ : KYMR) a commencé l'administration dans son essai clinique de phase 1b BroADen pour KT-621, un dégradateur oral de STAT6 de première classe, ciblant la dermatite atopique (DA) modérée à sévère. L'essai évaluera environ 20 patients adultes avec une dose quotidienne pendant 28 jours, en se concentrant sur la sécurité, la tolérabilité et l'activité clinique.
La société a terminé l'administration SAD/MAD dans l'essai de phase 1 chez des volontaires sains, avec des données attendues en juin 2025. Les résultats de l'essai BroADen sont prévus au quatrième trimestre 2025. De plus, Kymera prévoit de lancer deux essais parallèles de phase 2b : un pour la DA au quatrième trimestre 2025 et un autre pour l'asthme au premier trimestre 2026.
L'étude BroADen vise à démontrer que la dégradation de STAT6 dans le sang et la peau par KT-621 produit des effets similaires au dupilumab dans la réduction des biomarqueurs Th2. L'essai évaluera des critères cliniques tels que l'Eczema Area and Severity Index (EASI) et l'échelle numérique d'évaluation des démangeaisons (NRS).
Kymera Therapeutics (NASDAQ: KYMR) hat mit der Dosierung in der BroADen Phase-1b-Studie für KT-621 begonnen, einem neuartigen oralen STAT6-Degrader, der sich gegen mittelschwere bis schwere atopische Dermatitis (AD) richtet. Die Studie wird etwa 20 erwachsene Patienten mit einmal täglicher Dosierung über 28 Tage umfassen und konzentriert sich auf Sicherheit, Verträglichkeit und klinische Wirksamkeit.
Das Unternehmen hat die SAD/MAD-Dosierung in der Phase-1-Studie mit gesunden Probanden abgeschlossen, Daten werden für Juni 2025 erwartet. Die Ergebnisse der BroADen-Studie werden im 4. Quartal 2025 erwartet. Zudem plant Kymera den Start von zwei parallelen Phase-2b-Studien: eine für AD im 4. Quartal 2025 und eine weitere für Asthma im 1. Quartal 2026.
Die BroADen-Studie zielt darauf ab, zu zeigen, dass der Abbau von STAT6 im Blut und in der Haut durch KT-621 ähnliche Effekte wie Dupilumab bei der Reduktion von Th2-Biomarkern bewirkt. Klinische Endpunkte sind unter anderem der Eczema Area and Severity Index (EASI) und die numerische Bewertungsskala für Juckreiz (NRS).
- First-in-class oral STAT6 degrader advancing to patient trials
- Multiple clinical milestones expected in 2025-2026
- Potential to expand into multiple indications (dermatology, gastroenterology, respiratory)
- Development of convenient oral alternative to existing treatments
- Phase 1b results not expected until Q4 2025
- Early-stage clinical development with no efficacy data yet
- Significant time before potential market approval
Insights
Kymera's STAT6 degrader enters patient trials, marking progress for novel oral immunology drug with data expected later in 2025.
Kymera Therapeutics has achieved a significant clinical milestone with the dosing of the first patient in their BroADen Phase 1b trial for KT-621, a first-in-class oral STAT6 degrader targeting atopic dermatitis (AD). This advancement follows completed SAD/MAD dosing in healthy volunteers, with data expected in June 2025, while the AD patient trial results are anticipated in Q4 2025.
The BroADen trial design is particularly noteworthy as it aims to demonstrate that KT-621-induced STAT6 degradation produces similar effects to dupilumab on Th2 biomarkers. Dupilumab, a blockbuster biologic requiring injection, has set a high efficacy bar in AD treatment. If KT-621 shows comparable biological activity through an oral route, it could represent a significant convenience advantage for patients.
Kymera's accelerated development strategy is evident in their plans to initiate Phase 2b trials in both AD and asthma in Q4 2025 and Q1 2026 respectively, demonstrating confidence in their asset. This parallel development approach across multiple Th2-driven conditions suggests the company envisions a broad platform potential for their STAT6 degrader technology.
The scientific significance of targeting STAT6 shouldn't be underestimated - as a transcription factor central to allergic inflammatory pathways, it represents a novel approach distinct from current therapies. While JAK inhibitors provide oral options for AD, their safety concerns have adoption. A selective STAT6 degrader could potentially thread the needle between the convenience of oral administration and the safety profile needed for chronic inflammatory conditions.
Data from the BroADen Phase 1b atopic dermatitis (AD) patient trial expected to be reported in 4Q25
Completed SAD/MAD dosing in KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025
Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively
WATERTOWN, Mass., April 22, 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 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.
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. 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.
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.
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.
Availability of Other Information About Kymera Therapeutics
For more information, please visit the Kymera website at https://www.kymeratx.com/ or follow Kymera on X (@KymeraTx) and LinkedIn (Kymera Therapeutics). Investors and others should note that Kymera communicates with its investors and the public using the Company website, including, but not limited to, corporate disclosures, investor presentations, FAQs, Securities and Exchange Commission (SEC) filings, and press releases, as well as on X and LinkedIn. The information that Kymera posts on its website or on X or LinkedIn could be deemed to be material information. As a result, the Company encourages investors, the media and others interested to review the information that Kymera posts there on a regular basis. The contents of Kymera’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
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 the progress, timing and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, the advancement of KT-621 in Phase 1 clinical testing, the expectation that two parallel Phase 2b clinical trials are expected to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively and the intention to accelerate KT-621 development for subsequent parallel Phase 3 registration studies. 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: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future trials and the results of such trials, whether preclinical results will be indicative of the results of clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Annual Report on Form 10-K 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:
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FAQ
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