Kymera Therapeutics Presents New Preclinical Data for KT-579, a First-in-Class, Oral IRF5 Degrader, at the American College of Rheumatology Annual Meeting
Kymera Therapeutics (NASDAQ: KYMR) presented new preclinical data for KT-579, an oral IRF5 degrader, at the American College of Rheumatology Annual Meeting on Oct 27, 2025. The data show disease‑modifying activity across multiple lupus and rheumatoid arthritis models, including reductions in blood interferon‑stimulated genes, serum anti‑dsDNA autoantibodies, kidney IgG deposition, and protection from renal disease progression in lupus models, plus dose‑dependent joint swelling reduction and bone‑protection in RA models. In vitro human assays showed blockade of Th1‑skewing cytokines. The company intends to initiate Phase 1 testing in early 2026.
Kymera Therapeutics (NASDAQ: KYMR) ha presentato nuove dati preclinici per KT-579, un degrador IRF5 orale, alla riunione annuale dell'American College of Rheumatology il 27 ottobre 2025. I dati mostrano attività che modificano la malattia in modelli multipli di lupus e artrite reumatoide, tra cui riduzioni di geni stimolati dall'interferone nel sangue, autoanticorpi anti-dsDNA nel siero, deposito di IgG nei reni e protezione dalla progressione della malattia renale in modelli di lupus, oltre a una riduzione dose-dipendente del gonfiore delle articolazioni e protezione ossea nei modelli di RA. In saggi in vitro su umani è stata osservata l'inibizione delle citochine che orientano Th1. L'azienda intende avviare la sperimentazione di Fase 1 all'inizio del 2026.
Kymera Therapeutics (NASDAQ: KYMR) presentó nuevos datos preclínicos para KT-579, un degrador oral de IRF5, en la Reunión Anual del American College of Rheumatology el 27 de octubre de 2025. Los datos muestran una actividad que modifica la enfermedad en múltiples modelos de lupus y artritis reumatoide, incluyendo reducciones en genes estimulados por interferón en la sangre, autoanticuerpos anti-dsDNA en suero, depósito de IgG en los riñones y protección frente a la progresión de la enfermedad renal en modelos de lupus, además de una reducción dosis-dependiente de la hinchazón articular y protección ósea en modelos de AR. Los ensayos in vitro en humanos mostraron bloqueo de citocinas que sesgan Th1. La empresa tiene la intención de iniciar ensayos de Fase 1 a principios de 2026.
Kymera Therapeutics (NASDAQ: KYMR)은 KT-579라는 경구 IRF5 분해제에 대한 새로운 전임상 데이터를 2025년 10월 27일 American College of Rheumatology 연례 회의에서 발표했다. 데이터는 루푸스와 류마티스 관절염 모델에서 질병 수정 활성을 보이며, 혈액 내 인터페론 자극 유전자 감소, 혈청 anti-dsDNA 자가항체 감소, 신장 IgG 침착 감소, 루푸스 모델에서 신장 질환 진행 보호를 포함하고, RA 모델에서 관절 부종 감소 및 뼈 보호를 용량 의존적으로 보여준다. 인간의 in vitro 분석은 Th1 편향을 유도하는 사이토카인 차단을 나타냈다. 회사는 2026년 초에 1상 시험을 시작할 계획이다.
Kymera Therapeutics (NYSE: KYMR) a présenté de nouvelles données précliniques pour KT-579, un dégrader IRF5 oral, lors de la réunion annuelle de l'American College of Rheumatology le 27 octobre 2025. Les données démontrent une activité modifiant la maladie dans plusieurs modèles de lupus et d'arthrite rhumatoïde, notamment des diminutions des gènes stimulés par l'interféron dans le sang, des auto-anticorps anti-dsDNA dans le sérum, des dépôts d'IgG rénaux et une protection contre la progression de la maladie rénale dans les modèles lupiques, ainsi qu'une réduction dose-dépendante de l'enflure des articulations et une protection osseuse dans les modèles RA. Des essais in vitro sur l'homme ont montré le blocage des cytokinines qui orientent Th1. L'entreprise envisage de lancer des essais de phase 1 au début de 2026.
Kymera Therapeutics (NASDAQ: KYMR) präsentierte neue präklinische Daten zu KT-579, einem oralen IRF5-Degrader, auf dem jährlichen Meeting der American College of Rheumatology am 27. Oktober 2025. Die Daten zeigen eine krankheitsmodifizierende Aktivität in mehreren Lupus- und rheumatoider Arthritis-Modellen, einschließlich Reduktionen der blutigen interferon-stimulierten Gene, Serum-Anti-dsDNA-Autoantikörper, Nieren-IgG-Besiedelung und Schutz vor dem Fortschreiten der Nierenerkrankung in Lupus-Modellen, sowie dosisabhängige Verringerung der Gelenkschwellung und Knochenschutz in RA-Modellen. In vitro-Humane Assays zeigten Blockade von Th1-gerichteten Zytokinen. Das Unternehmen beabsichtigt, im frühen 2026 mit Phase-1-Tests zu beginnen.
Kymera Therapeutics (مدرجة في ناسداك: KYMR) قدمت بيانات جديدة قبل السريرية لـ KT-579، وهو مثبِّط IRF5 فموي، في الاجتماع السنوي للجمعية الأمريكية لعلم الروماتيزم في 27 أكتوبر 2025. تُظهر البيانات نشاطاً يغير مجرى المرض عبر نماذج متعددة من الذئبة والتهاب المفاصل الروماتويدي، بما في ذلك انخفاض في جينات متحسسة بالإنترفيرون في الدم، وأجسام مضادة مضادة-dsDNA في المصل، وترسب IgG الكلوي، وحماية من تقدم مرض الكلى في نماذج الذئبة، بالإضافة إلى انخفاض مستند إلى الجرعة في تورم المفاصل وحماية العظام في نماذج RA. أظهرت الاختبارات البشرية المعملية عرقلة السيتوكينات المُوجهة لـ Th1. تخطط الشركة لبدء اختبارات المرحلة 1 في أوائل 2026.
Kymera Therapeutics (NASDAQ: KYMR) 在 2025 年 10 月 27 日的美国风湿病学会年会上公布了 KT-579 的新前临床数据，该药为口服 IRF5 降解剂。数据在多种系统性红斑狼疮和类风湿性关节炎模型中显示出疾病修饰活性，包括血液中干扰素刺激基因的降低、血清抗 dsDNA 自身抗体、肾脏 IgG 沉积的减少，以及在狼疮模型中对肾病进展的保护；在 RA 模型中观察到剂量依赖性的关节肿胀下降和骨保护。在体外的人类实验中显示对 Th1 偏向性细胞因子的阻断。公司计划在 2026 年初启动 1 期试验。
- Preclinical reductions in blood interferon‑stimulated genes
- Lowered serum anti‑dsDNA autoantibodies in lupus models
- Protected from renal disease progression in spontaneous lupus mice
- Dose‑dependent reduction of joint swelling in RA rodent models
- In vitro blockade of Th1‑skewing cytokines in human co‑cultures
- Phase 1 testing planned for early 2026
- Evidence is preclinical; no human clinical efficacy data reported
- Comparisons described as "comparable or superior" are based on preclinical models only
Insights
Preclinical IRF5 degradation shows disease‑modifying signals across lupus and RA models; Phase 1 planned in
KT-579 produced multi‑model pharmacology: reductions in Type I IFN signaling, serum anti‑dsDNA autoantibodies, kidney IgG deposition and protection from renal disease in spontaneous lupus models, and dose‑dependent reduction of joint swelling with correlated cytokine and Th1 inhibition in RA rodent models. In vitro human co‑culture work showed blockade of Th1‑skewing cytokines by KT‑579, supporting the in vivo mechanism.
The evidence links target engagement (IRF5 degradation) to downstream pathways and organ‑level benefit in animals and to immune modulation in human cells; however, these are preclinical endpoints and human safety, PK/PD and target modulation remain unknown until first‑in‑human testing. The announced initiation of Phase 1 in
Watch for initial Phase 1 readouts on safety, human PK and evidence of IRF5 degradation or downstream biomarker changes (Type I IFN gene signature, cytokine levels) within the first clinical cohort over the next 6–12 months after trial start; those data will materially affect clinical confidence.
Robust preclinical activity and a near‑term Phase 1 start make this a materially positive development for the program.
The program demonstrates consistent efficacy signals across multiple disease models and human primary cell systems, and the company states activity comparable or superior to approved or clinically active agents in the presented assays, which supports a clear rationale to advance to first‑in‑human testing. The planned Phase 1 initiation in
Key dependencies include human safety, tolerability and proof of target engagement; the earliest meaningful readouts will be safety and biomarker effects reported from the Phase 1 trial. Expect initial clinical data within months after dosing begins; these will determine whether preclinical efficacy signals have translational potential.
KT-579, a potent, selective, oral degrader of IRF5, demonstrated broad activity across multiple preclinical models of lupus and rheumatoid arthritis (RA), with activity comparable or superior to approved and clinically active therapies
KT-579 Phase 1 testing expected to begin in early 2026
WATERTOWN, Mass., Oct. 27, 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 the presentation of new preclinical data for KT-579, its potent, selective, oral IRF5 degrader, demonstrating disease-modifying activity across multiple immuno-inflammatory diseases. The findings show that by selectively targeting and degrading IRF5, a master regulator of immune responses, KT-579 offers a novel oral approach to suppress multiple pro-inflammatory pathways implicated in diseases such as lupus and rheumatoid arthritis (RA). These data were presented at the American College of Rheumatology (ACR) Convergence Annual Meeting being held October 24-29, 2025, in Chicago, IL.
“KT-579’s compelling and consistent preclinical data demonstrating reductions in autoimmune symptoms and disease underscores the transformative potential of targeted protein degradation to address the pathogenic functions of IRF5 in specific disease contexts,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “By modulating this historically undrugged driver of multiple inflammatory cascades, we believe KT-579 could represent a transformative oral treatment for patients with complex rheumatic and autoimmune diseases, such as lupus and RA, who remain underserved by existing therapies.”
The Company previously shared data demonstrating KT-579’s encouraging profile in preclinical studies using human primary cell systems, patient-derived cells, and in vivo disease models, showing activity comparable or superior to existing standards of care. The new data presented at ACR further highlight KT-579’s robust activity across preclinical efficacy models of lupus and RA. In spontaneous lupus mouse models, KT-579 significantly impacted Type I IFN signaling and pathogenic B cell subsets, key molecular pathways known to be involved in lupus pathogenesis, that resulted in marked reductions of blood interferon-stimulated genes, serum autoantibodies (anti-dsDNA), kidney IgG deposition, and protected from renal disease progression. In RA rodent models, KT-579 achieved a dose-dependent reduction of joint swelling that correlated with inhibition of pro-inflammatory cytokines and Th1 responses in joint tissue and protected from bone destruction. Consistent with these in vivo mechanistic results, in vitro human co-culture experiments demonstrated that KT-579 can block Th1-skewing cytokines in monocytes, preventing pathogenic T cell differentiation and further validating its potential to rebalance immune responses.
Collectively, these findings reinforce KT-579’s multifaceted mechanism and its potential as a transformative oral therapy for rheumatic and autoimmune diseases driven by IRF5 dysregulation, such as lupus, RA, Sjögren’s, inflammatory bowel disease (IBD), among others. The Company intends to initiate Phase 1 testing for KT-579 in early 2026.
American College of Rheumatology (ACR) Convergence Annual Meeting
Title: Potent and Selective Oral IRF5 Degrader, KT-579, Demonstrates In Vitro and In Vivo Activity Comparable or Superior to Approved or Clinically Active Agents in Human Cellular Assays and Lupus Efficacy Models
Type/Session: Poster, B Cell Biology & Targets in Autoimmune & Inflammatory Disease
Speaker: Veroncia Campbell, Senior Director, Immunology
Date/Time: Monday, October 27, 2025, at 10:30AM -12:30PM CT
Title: Potent and Selective Oral IRF5 Degrader, KT-579, Blocks Pro-Inflammatory Cytokines and Reduces Joint Swelling in Rodent Models of Rheumatoid Arthritis
Type/Session: Poster, Innate Immunity
Speaker: Ryan Camire, PhD, Scientist, Immunology
Date/Time: Monday, October 27, 2025, at 10:30AM -12:30PM CT
Copies of the ACR presentations are available in the Resource Library section of Kymera's website.
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, and the advancement of KT-579 into Phase 1 clinical testing in early 2026. 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 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.
Investor and Media Contact:
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FAQ
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