Kymera Therapeutics, Inc. (NASDAQ: KYMR) has announced the dosing of the first participant in its Phase 1 clinical trial evaluating KT-621, a first-in-class oral STAT6 degrader, for the treatment of TH2 immuno-inflammatory diseases. This marks a significant milestone as KT-621 is the first STAT6-targeted medicine to enter clinical development, offering a potential new approach to address allergic and atopic diseases.
Clinical Trial Details
The Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered KT-621 in healthy volunteers. The study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Kymera expects to report Phase 1 data in the first half of 2025.
STAT6 Degrader: A Novel Approach
STAT6 is an essential transcription factor in the IL-4/IL-13 signaling pathways, driving T helper type 2 (TH2) inflammation in allergic diseases. Dupilumab, an injectable monoclonal antibody targeting IL-4/IL-13 signaling, is an approved therapy for these conditions. However, STAT6 has been challenging to target with traditional small molecule inhibitors due to its protein-protein and protein-DNA interactions.
KT-621 is an investigational once-daily, oral STAT6 degrader designed to overcome these challenges. Preclinical models have demonstrated dupilumab-like activity and good tolerability, suggesting its potential to treat various allergic and atopic diseases, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease.
Executive Commentary
"KT-621 is the first oral STAT6 targeted medicine to advance into the clinic, showcasing Kymera’s drug discovery capabilities that address previously undrugged disease-causing proteins," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "We believe KT-621 can provide the convenience of a once daily oral pill with the potential to deliver biologic-like activity for patients suffering from highly prevalent allergic and atopic diseases around the world."
Strategic Focus and Financial Stability
Kymera's focus is on immunology with several catalysts expected in the next year. The company is preparing for increased activity, including commercialization discussions for KT-621. Kymera raised $600 million, securing financial runway into mid-2027.
