Kymera Therapeutics Announces First Patient Dosed in Phase 2 Atopic Dermatitis Clinical Trial of KT-474 (SAR444656), a First-in-Class, Investigational IRAK4 Degrader, Generating a $15 Million Payment from Sanofi

Atopic Dermatitis (AD) trial is the second KT-474 Phase 2 clinical trial to begin enrolling patients this quarter following trial in Hidradenitis Suppurativa (HS)

Topline Phase 2 data from both the AD and HS trials expected in the first half of 2025

WATERTOWN, Mass., Dec. 07, 2023 (GLOBE NEWSWIRE) -- (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that the first patient has been dosed in the randomized Phase 2 clinical trial (ADVANTA) evaluating KT-474 (SAR444656) in AD, generating a $15 million milestone payment under its collaboration with Sanofi. The Phase 2 study will evaluate the efficacy and safety of KT-474, a first-in-class, investigational IRAK4 degrader, compared with placebo in adult patients with moderate to severe AD. Sanofi is conducting Phase 2 KT-474 studies in both AD and HS, and dosed the first HS patient in , which generated a $40 million milestone payment under the terms of the collaboration. Study completion dates for both trials are projected in the first quarter of 2025.

“The initiation of dosing in the second Phase 2 trial of KT-474 reinforces the potential of degrading IRAK4 in the treatment of multiple immunological and inflammatory diseases, and the promise of TPD to offer patients with complex inflammatory diseases a new way to manage their disease,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Our focus has always been on genetically validated targets within pathways with clear clinical validation and where TPD offers the best or the only path to creating an effective treatment, and we believe our IRAK4 degrader has the potential to offer AD patients a well-tolerated, effective, and convenient oral medicine. We look forward to sharing updates as our partner Sanofi progresses this program.”

“While we’ve made great strides in the treatment of AD, there continues to be an opportunity to advance a diverse range of solutions that address unmet needs across the spectrum of patients suffering from this chronic condition,” said Naimish Patel, MD, Head of Global Development, Immunology and Inflammation, Sanofi. “We are pleased to be working with Kymera to explore the potential of IRAK4 degradation to treat a variety of inflammatory conditions, including in our recently initiated Phase 2 AD and HS trials.”

About KT-474

KT-474 is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflammatory diseases where there is an opportunity to significantly advance the standard of care, including HS and AD. The Phase 1 clinical trial results were recently published in and showed evidence of robust IRAK4 degradation in the blood and active skin lesions of HS and AD patients and a favorable safety profile. Treatment with KT-474 was associated with a systemic anti-inflammatory response and improvement in skin lesions and symptoms in both HS and AD patients, with internal consistency between the effect on inflammatory biomarkers and impact on clinical endpoints. KT-474 was generally safe and well-tolerated, with no serious adverse events, no drug-related infections, and no dose interruptions or discontinuations due to adverse events.

The safety and efficacy of KT-474 (SAR444656) is currently being evaluated in double blind, placebo-controlled, randomized Phase 2 clinical trials in adult patients with moderate to severe HS and AD. Sanofi, which is collaborating with Kymera on the development of KT-474 outside of the oncology and immune-oncology fields, is conducting the Phase 2 studies.

More information on the Phase 2 studies in HS (NCT06028230) and AD (NCT06058156) can be found at .

About 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 is a common condition that usually begins in childhood; however, anyone can get the disease. 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, there is a significant opportunity to improve treatment for patients not effectively treated with currently available options.

About Kymera Therapeutics

Kymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule programs designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera’s initial programs target IRAK4 and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.

Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science and pipeline, please visit or follow us on or .

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