Kymera Therapeutics Announces Dosing of First Participant in Phase 1 Clinical Trial of KT-621, a First-in-Class Oral STAT6 Degrader, for the Treatment of TH2 Immuno-Inflammatory Diseases
Kymera Therapeutics (NASDAQ: KYMR) has initiated dosing in a Phase 1 clinical trial for KT-621, the first-ever oral STAT6 degrader to enter clinical development. The trial evaluates safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers through single and multiple ascending dose cohorts. KT-621 demonstrated dupilumab-like activity in preclinical models for treating TH2 immuno-inflammatory diseases, with potential as a convenient once-daily oral alternative to injectable treatments. Phase 1 data is expected in the first half of 2025.
Kymera Therapeutics (NASDAQ: KYMR) ha avviato la somministrazione in uno studio clinico di Fase 1 per KT-621, il primo degrader orale di STAT6 mai entrato nello sviluppo clinico. Lo studio valuta la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica in volontari sani attraverso coorti di dosi ascendenti singole e multiple. KT-621 ha dimostrato un'attività simile a quella del dupilumab in modelli preclinici per il trattamento di malattie immuno-infiammatorie TH2, con il potenziale di essere un'alternativa orale pratica da assumere una volta al giorno rispetto ai trattamenti iniettabili. I dati della Fase 1 sono attesi nella prima metà del 2025.
Kymera Therapeutics (NASDAQ: KYMR) ha iniciado la administración en un ensayo clínico de Fase 1 para KT-621, el primer degradador oral de STAT6 en entrar en desarrollo clínico. El ensayo evalúa la seguridad, la tolerabilidad, la farmacocinética y la farmacodinamia en voluntarios sanos a través de cohortes de dosis únicas y múltiples en ascenso. KT-621 demostró actividad similar a la del dupilumab en modelos preclínicos para el tratamiento de enfermedades inmuno-inflamatorias TH2, con el potencial de ser una alternativa oral conveniente que se toma una vez al día en lugar de tratamientos inyectables. Se esperan datos de Fase 1 en la primera mitad de 2025.
Kymera Therapeutics (NASDAQ: KYMR)는 최초의 경구용 STAT6 분해제인 KT-621에 대한 1상 임상 시험에서 투여를 시작했습니다. 이 시험은 건강한 자원봉사자를 대상으로 단일 및 다단계 용량 증량 집단을 통해 안전성, 내약성, 약물동태 및 약물동역학을 평가합니다. KT-621은 TH2 면역 염증 질환 치료를 위한 전임상 모델에서 dupilumab과 유사한 활성을 보여주었으며, 주사 치료의 편리한 일일 경구 대안으로서의 가능성이 있습니다. 1상 데이터는 2025년 상반기에 발표될 예정입니다.
Kymera Therapeutics (NASDAQ: KYMR) a débuté l'administration dans un essai clinique de Phase 1 pour KT-621, le premier dégradateur oral de STAT6 à entrer en développement clinique. L'essai évalue la sécurité, la tolérance, la pharmacocinétique et la pharmacodynamie chez des volontaires sains à travers des cohortes de doses uniques et multiples en augmentation. KT-621 a montré une activité similaire à celle du dupilumab dans des modèles précliniques pour le traitement des maladies immuno-inflammatoires TH2, avec le potentiel d'être une alternative orale pratique à prise quotidienne par rapport aux traitements injectables. Les données de la Phase 1 sont attendues dans la première moitié de 2025.
Kymera Therapeutics (NASDAQ: KYMR) hat die Dosierung in einer klinischen Studie der Phase 1 für KT-621, den ersten oralen STAT6-Degrader, der in die klinische Entwicklung eintritt, begonnen. Die Studie bewertet die Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik bei gesunden Probanden durch einzelne und multiple aufsteigende Dosierungskohorten. KT-621 zeigte in präklinischen Modellen eine dupilumab-ähnliche Aktivität bei der Behandlung von TH2- immunoinflammatorischen Erkrankungen und hat das Potenzial, eine praktische einmal täglich einzunehmende orale Alternative zu injizierbaren Behandlungen zu sein. Die Daten der Phase 1 werden in der ersten Hälfte von 2025 erwartet.
- First-in-class oral STAT6 degrader entering clinical trials
- Demonstrated comparable activity to existing injectable treatment (dupilumab) in preclinical studies
- Potential for more convenient once-daily oral administration versus injectables
- Phase 1 results not expected until first half of 2025
- Early-stage development with no proven clinical efficacy yet
Insights
The initiation of Phase 1 trials for KT-621 marks a significant milestone in the immuno-inflammatory disease treatment landscape. This first-in-class oral STAT6 degrader could potentially disrupt the current treatment paradigm dominated by injectable biologics like dupilumab.
The key differentiator is KT-621's oral administration route, which addresses a major convenience barrier in the current standard of care. Preclinical data suggesting comparable efficacy to dupilumab is particularly noteworthy, as dupilumab (Dupixent) generated
The targeted protein degradation approach for STAT6 represents a novel mechanism in treating TH2-driven diseases like atopic dermatitis and asthma. If successful, this could create a new therapeutic class with significant market potential, given the high prevalence of allergic and atopic conditions globally.
KT-621, an oral degrader, is the first STAT6 targeted medicine to enter clinical development, with the potential to address multiple immuno-inflammatory diseases
KT-621 has demonstrated dupilumab-like activity and was well tolerated in a wide variety of preclinical models of TH2 diseases
Phase 1 healthy volunteer data expected to be reported in the first half of 2025
WATERTOWN, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that it recently initiated dosing in the Phase 1 clinical trial in the US evaluating KT-621, a potent, selective, oral degrader of STAT6, in adult healthy volunteers. The Company expects to report Phase 1 data in the first half of 2025.
“KT-621 is the first oral STAT6 targeted medicine to advance into the clinic, showcasing Kymera’s drug discovery capabilities that address previously undrugged disease-causing proteins that have been elusive for existing modalities,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “We believe KT-621 can provide the convenience of a once daily oral pill with the potential to deliver biologic-like activity for patients suffering from highly prevalent allergic and atopic diseases around the world. We generated a comprehensive preclinical package for KT-621 that demonstrated that STAT6 degradation leads to the same level of pathway blockade as an injectable IL-4Rα antibody like dupilumab, with an excellent tolerability profile. We are excited to progress this wholly-owned asset through this Phase 1 healthy volunteer study, and subsequently into patients.”
The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered KT-621 in healthy volunteers. The study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. More information on the KT-621 Phase 1 study will be available on www.clinicaltrials.gov.
About STAT6 Degrader
STAT6 is a historically undrugged essential transcription factor in the IL-4/IL-13 signaling pathways and the central driver of T helper type 2 (TH2) inflammation in allergic diseases. Multiple gain of function mutations of STAT6 were identified to cause severe allergic diseases in humans. Dupilumab, an injectable monoclonal antibody that blocks IL-4/IL-13 signaling, is an approved therapy for multiple allergic and atopic diseases. STAT6 targeting is therefore supported by both human genetics and clinical pathway validation. STAT6 functions through protein-protein and protein-DNA interactions, and it has been challenging to selectively and potently inhibit STAT6 with small molecule inhibitors. However, we believe it is well suited for a targeted protein degradation approach, where a binding event is sufficient to drive degradation. KT-621 is an investigational first-in-class once daily, oral STAT6 degrader with dupilumab-like activity in preclinical models and the potential to address multiple allergic and atopic diseases including atopic dermatitis, asthma, and chronic obstructive pulmonary disease, among others. Kymera has initiated dosing in the KT-621 Phase 1 trial and expects data from the study to be reported in the first half of 2025.
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 delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. 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 (previously Twitter) 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 clinical development of KT-621. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” 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 results of preclinical studies and clinical trials may not be predictive of future results in connection with current and future clinical trials, uncertainties inherent in the initiation of future clinical trials, the timing and anticipated results of current and future clinical trials, whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, 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 Securities and Exchange Commission. 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
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