In the Phase 1 trial, KT-474 showed evidence of robust IRAK4 degradation in blood and skin lesions as well as a systemic anti-inflammatory effect in hidradenitis suppurativa (HS) and atopic dermatitis (AD) patients and was generally well-tolerated

Clinical endpoints addressing disease burden and symptoms demonstrated a highly competitive profile with substantial responses in the majority of both HS and AD patients with moderate-to-severe disease

Kymera’s partner Sanofi to initiate Phase 2 clinical trials of KT-474 in HS and AD, with first study in HS planned for initiation in 2023

WATERTOWN, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today presented positive Phase 1 clinical data from its lead program, KT-474 (SAR444656), a potent, highly selective, orally bioavailable IRAK4 degrader. The Company delivered an oral presentation at the European Academy of Dermatology and Venereology (EADV) Symposium, taking place from May 18-20, 2023, in Seville, Spain.

IRAK4 is a key protein involved in inflammation mediated by the activation of toll-like receptors (TLRs) and IL-1 receptors (IL-1Rs). Aberrant activation of these pathways is the underlying cause of multiple immune-inflammatory conditions. KT-474, a potential first-in-class IRAK4 degrader, is in development for the treatment of TLR/IL-1R-driven immune-inflammatory diseases with high unmet medical need, such as hidradenitis suppurativa (HS), atopic dermatitis (AD), and potentially others. KT-474 is designed to block TLR/IL-1R-mediated inflammation more broadly compared to monoclonal antibodies targeting single cytokines, and to enable pathway inhibition that is superior to IRAK4 kinase inhibitors by abolishing both the kinase and scaffolding functions of IRAK4, thereby providing a novel therapeutic approach.

The data demonstrated that KT-474 administered to HS and AD patients had safety, PK and PD similar to healthy volunteers, achieved robust IRAK4 degradation in blood and skin associated with a systemic anti-inflammatory effect, and showed promising clinical activity in HS and AD. The Company previously reported on the full data set in December, and today’s presentation marks the first time these results have been shared at a major scientific meeting.

“The KT-474 Phase 1 trial was a substantial accomplishment for Kymera, showcasing the high fidelity of PK/PD and safety translation from preclinical species to humans for our heterobifunctional degrader platform. KT-474 exhibited clinical activity in HS and AD patients that we believe is superior to IRAK4 small molecule kinase inhibitors and appears competitive with standard of care biologics and other agents in development in both HS and AD,” said Jared Gollob, M.D., Chief Medical Officer at Kymera Therapeutics. “These results validate IRAK4 degradation as a potential best-in-class mechanism in TLR/IL-1R-driven inflammatory diseases that has the potential to improve the lives of patients with conditions like HS and AD and potentially other indications. We look forward to sharing additional updates as our partner Sanofi initiates Phase 2 clinical trials of KT-474 in HS and AD, with the first study in HS planned for initiation in 2023.”

Presentation at EADV
Title: Safety and Efficacy of IRAK4 Degrader KT-474 (SAR444656) for Hidradenitis Suppurativa and Atopic Dermatitis
Presentation ID: FC02.05
Session Time: 11:45 – 12:00 PM CEST, May 18, 2023
Location: Auditorium 3
Presenter: Jared Gollob, M.D., Chief Medical Officer, Kymera Therapeutics

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 www.kymeratx.com or follow us on 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 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 impact of COVID-19 on countries or regions in which we have operations or do business, as well as on 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, 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; 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 year ended December 31, 2022 filed on February 23, 2023, 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.