Kymera Update: First Patient Dosed in Phase 2 AD Clinical Trial of KT-474, a First-in-Class Investigational IRAK4 Degrader

The Phase 2 study will evaluate the efficacy and safety of KT-474, compared with placebo in adult patients with moderate to severe AD.

The first patient has been dosed in the Phase 2 clinical trial (ADVANTA) evaluating KT-474 in AD, generating a $15 million milestone payment under its collaboration with Sanofi. 

KT-474 is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflammatory diseases, including HS and AD.

The Phase 2 study will evaluate the efficacy and safety of KT-474, a first-in-class, investigational IRAK4 degrader, compared with placebo in adult patients with moderate to severe AD. Sanofi is conducting Phase 2 KT-474 studies in both AD and HS, and dosed the first HS patient in October 2023, which generated a $40 million milestone payment under the terms of the collaboration. Study completion dates for both trials are projected in the first quarter of 2025.

“The initiation of dosing in the second Phase 2 trial of KT-474 reinforces the potential of degrading IRAK4 in the treatment of multiple immunological and inflammatory diseases, and the promise of TPD to offer patients with complex inflammatory diseases a new way to manage their disease,” says Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics, in a news release. “Our focus has always been on genetically validated targets within pathways with clear clinical validation and where TPD offers the best or the only path to creating an effective treatment, and we believe our IRAK4 degrader has the potential to offer AD patients a well-tolerated, effective, and convenient oral medicine. We look forward to sharing updates as our partner Sanofi progresses this program.”

“While we’ve made great strides in the treatment of AD, there continues to be an opportunity to advance a diverse range of solutions that address unmet needs across the spectrum of patients suffering from this chronic condition,” adds Naimish Patel, MD, Head of Global Development, Immunology and Inflammation, Sanofi. “We are pleased to be working with Kymera to explore the potential of IRAK4 degradation to treat a variety of inflammatory conditions, including in our recently initiated Phase 2 AD and HS trials.”