Kymera Therapeutics, Inc. (NASDAQ:KYMR) on Monday released clinical results from the BroADen Phase 1b atopic dermatitis (AD) clinical trial of KT-621, its oral STAT6 degrader medicine.
STAT6 degradation is a novel oral approach for blocking the IL-4/IL-13 pathways in development for the treatment of atopic dermatitis and other allergic diseases.
“The BroADen study results exceeded our highest expectations and provide a powerful additional validation of our industry-leading STAT6 degrader program,” said Nello Mainolfi, Founder, President, and CEO, Kymera Therapeutics.
“The results were in line with, or in some cases numerically exceeded, published data for dupilumab at week 4, and we believe further reinforce Kymera’s pioneering expertise in developing transformative oral small molecules with the potential for the activity and safety of injectable biologics,” Mainolfi said in a press release on Monday.
Dupixent (dupilumab) is a prescription drug from Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).
KT-621 demonstrated deep and consistent STAT6 degradation in both blood and skin across the 100 mg and 200 mg dose groups.
At Day 29, median STAT6 degradation in blood was 98% at both the 100 mg and 200 mg doses.
In skin lesions, where STAT6 levels were 2-fold higher compared to healthy volunteers, KT-621 achieved median STAT6 degradation of 94% at both the 100 mg and 200 mg doses, with multiple subjects’ STAT6 levels dropping below the lower limit of quantification.
Type 2 Inflammation Biomarkers Show Robust Reductions
KT-621 achieved strong reductions in disease-relevant Type 2 biomarkers in blood, including a validated biomarker of Type 2 inflammation, Thymus and Activation-Regulated Chemokine (TARC).
Reductions with KT-621 were robust and associated with baseline levels of TARC in treated patients, consistent with reported dupilumab studies across multiple diseases.
In Fractional Exhaled Nitric Oxide (FeNO), a validated biomarker of Type 2 lung inflammation in asthma patients, KT-621 achieved median FeNO reductions at Day 29 of 25% and 33% among all patients within the 100 mg and 200 mg dose groups, respectively.
Encouraging clinical activity was observed across all disease endpoints measured, including a mean 63% Eczema Area and Severity Index (EASI) reduction and a mean 40% peak pruritus (itch) NRS reduction for all patients.
KT-621 was well-tolerated with a favorable safety profile consistent with the Phase 1a healthy volunteer trial results.
The KT-621 BROADEN2 Phase 2b trial in moderate to severe AD patients is ongoing, and patient dosing has commenced. Data is expected to be reported by mid-2027.
The BREADTH Phase 2b trial in asthma is planned to start in the first quarter of 2026.
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