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Kymera Therapeutics Announces FDA Clearance of Investigational New Drug Application for KT-621, a First-in-Class, Oral STAT6 Degrader
KT-621 has demonstrated dupilumab-like activity and was well tolerated ina wide variety of preclinical models of TH2 diseases KT-621 is expected to start
About this update from Kymera Therapeutics, Inc.
[{"type":"text","content":"KT-621 has demonstrated dupilumab-like activity and was well tolerated ina wide variety of preclinical models of TH2 diseases KT-621 is expected to start Phase 1 in October, with Phase 1 data in the first half of 2025 WATERTOWN, Mass., Oct. 09, 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 the clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for KT-621, a potent, selective, oral degrader of STAT6. The Company expects to initiate dosing in a Phase 1 clinical trial in healthy volunteers in October 2024 and to report data from the Phase 1 study in the first half of 2025. “FDA clearance of the KT-621 IND is a significant milestone for Kymera, patients, and the whole industry, allowing Kymera to be the first company to advance a STAT6 targeted medicine into clinical evaluation,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “Unlike traditional oral small molecule inhibitors, we believe that our oral STAT6 degrader, KT-621, has the potential to combine the complete pathway blockade of upstream biologics with the convenience of oral administration and in doing so has the opportunity to transform the current treatment paradigm for atopic and allergic diseases. We are excited to advance KT-621 into Phase 1 clinical testing and look forward to sharing updates on this program in the near future.” The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of KT-621 compared to placebo. 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 bee...