Kymera Therapeutics Announces First Patient Dosed in Phase 2 Hidradenitis Suppurativa Clinical Trial of KT-474 (SAR444656), a First-in-Class, Investigational IRAK4 Degrader, Generating $40 Million Payment from Sanofi

WATERTOWN, Mass., Oct. 27, 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 in hidradenitis suppurativa (HS) evaluating KT-474 (SAR444656), a first-in-class, investigational IRAK4 degrader. The Phase 2 study will evaluate the efficacy, safety, pharmacokinetics, and biological effects of KT-474 compared with placebo in adult patients with moderate to severe HS. Kymera’s partner Sanofi is conducting the Phase 2 study in HS, and has initiated a second randomized Phase 2 trial in AD. Under the terms of the collaboration, dosing of the first patient in the HS trial generated a milestone payment of $40 million. Dosing of the first patient in the AD trial will also generate a milestone payment to Kymera.

“The initiation of dosing in the first Phase 2 trial of KT-474 in HS is an important step in the development of this molecule and a significant achievement for Kymera in demonstrating the potential of protein degradation to transform the treatment of complex, inflammatory diseases with small molecules,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Based on the encouraging KT-474 Phase 1 results, we believe that this molecule has the potential to offer HS patients a well-tolerated and effective oral drug. We look forward to sharing additional updates as our partner Sanofi advances this program, including dosing the first patient in the second Phase 2 trial in AD later this quarter.”

“At Sanofi, we’ve very excited about the potential of protein degraders to deliver new treatments for immunological and inflammatory diseases by selectively targeting specific proteins and critical pathways, like IRAK4,” said Naimish Patel, MD, Head of Global Development, Immunology and Inflammation, Sanofi. “HS is a chronic, debilitating skin disease whereby there remains a tremendous need for new treatment options. We look forward to progressing the Phase 2 program in HS and AD.”

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. In the Phase 1 trial, KT-474 showed evidence of robust IRAK4 degradation in the blood and active skin lesions of HS and AD patients and was generally well tolerated. 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 (NTC06058156) can be found at .

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that causes painful lumps deep in the skin. It results in painful nodules and abscesses that can persist and worsen over time. It can affect daily life and emotional well-being, especially as the disease progresses. HS tends to start after puberty, usually before age 40. There are no FDA approved oral treatments for HS.

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, IRAKIMiD, 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 .

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 by Kymera Therapeutics regarding its: strategy, business plans and objectives for the IRAK4, IRAKIMiD, STAT3, and MDM2 degrader programs; plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials; the ability to initiate new clinical programs; and Kymera’s financial condition and expected cash runway into the second half of 2025. 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 those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics' drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for KT-474 (SAR444656), KT-333, KT-413 and KT-253; Kymera Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics' planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; the risks associated with pandemics or epidemics; and Kymera Therapeutics' relationships with its existing and future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the Annual Report on Form 10-K for the period ended December 31, 2022 and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics' subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims 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.