Kymera Therapeutics Announces Positive First-in-Human Results from Phase 1 Healthy Volunteer Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader

Core Insights - Kymera Therapeutics announced positive Phase 1 results for KT-621, a once-daily oral STAT6 degrader, which exceeded expectations and demonstrated a robust safety profile [1][2][3] Study Results - KT-621 achieved over 90% mean STAT6 degradation in blood at all doses above 1.5 mg, with complete degradation in both blood and skin at doses ≥50 mg [1][3][9] - The drug demonstrated a median TARC reduction of up to 37% and a median Eotaxin-3 reduction of up to 63%, indicating its potential effectiveness compared to dupilumab [1][11] - The safety profile of KT-621 was comparable to placebo, with no serious adverse events reported and no clinically relevant changes in vital signs or lab tests [1][12] Study Design - The Phase 1 trial was a double-blind, placebo-controlled study involving 118 healthy volunteers, assessing the safety and tolerability of escalating doses of KT-621 [4][5] - Single ascending doses ranged from 6.25 to 800 mg, while multiple ascending doses were administered daily for 14 days at levels from 1.5 to 200 mg [5][6] Pharmacokinetics and Pharmacodynamics - KT-621 exhibited rapid absorption with a median time to maximum concentration (tmax) of 2-4 hours and a mean half-life of 9-36 hours [6] - The drug demonstrated deep and prolonged STAT6 degradation in blood and skin, with steady-state achieved by Day 4 [6][9][10] Next Steps - The ongoing BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients is expected to report data in Q4 2025 [1][13] - Two parallel Phase 2b trials in AD and asthma are planned to commence in Q4 2025 and Q1 2026, respectively [1][13] Company Overview - Kymera Therapeutics is focused on developing oral small molecule degrader medicines for immunological diseases, aiming to provide treatments with the convenience of oral administration and the efficacy of injectable biologics [1][16][17]