Kymera Therapeutics doses first participant in KT-485 Phase 1 trial
Kymera Therapeutics, Inc. has dosed the first participant in a Phase 1 trial for KT-485, triggering a $20 million milestone payment from Sanofi. The trial evaluates the oral IRAK4 degrader in healthy volunteers and hidradenitis suppurativa patients. Kymera is eligible for up to $975 million in milestones and retains US co-promotion rights.
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Kymera Therapeutics, Inc. has dosed the first participant in a first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral IRAK4 degrader, triggering a $20 million milestone payment from its partner Sanofi. The trial is assessing the therapy in adult healthy volunteers and patients with hidradenitis suppurativa (HS). This advancement marks a significant step in the collaboration between the two companies to develop novel oral treatments for immuno-inflammatory diseases.
Sanofi is leading the development, regulatory, and commercial efforts for the KT-485 program. Under the collaboration agreement, Kymera is eligible to receive up to $975 million in potential clinical, regulatory, and commercial milestones. The company retains an option to participate in future development and commercialization in the United States, with a 50/50 profit split, and is entitled to double-digit tiered royalties in the rest of the world (ROW).
Trial Details and Design
The Phase 1 trial (NCT07629336) is designed to evaluate the safety, tolerability, pharmacokinetics, and additional exploratory endpoints of orally administered KT-485. The study consists of three parts:
- Double-blind, placebo-controlled single ascending dose (SAD) cohorts
- Double-blind, placebo-controlled multiple ascending dose (MAD) cohorts
- An open-label MAD cohort
About KT-485
KT-485 is a second-generation oral degrader of IRAK4, a scaffolding kinase and key protein of the myddosome complex that mediates signaling through IL-1 and toll-like receptors. By eliminating IRAK4 completely through degradation, the therapy aims to impact both kinase and scaffolding functions. Preclinical testing demonstrated increased potency and specificity with a favorable safety profile.
| Feature | Description |
|---|---|
| Target | IRAK4 degrader |
| Generation | Second generation |
| Administration | Oral |
| Indication | Immuno-inflammatory diseases |
"Advancing KT-485, our second generation IRAK4 degrader, into the clinic is an important milestone for our collaboration with Sanofi and our efforts to ultimately bring this important oral therapy to patients," said Nello Mainolfi, PhD, Founder, President and CEO of Kymera Therapeutics.
What are the anticipated timelines for the release of initial safety and pharmacokinetic data from the Phase 1 trial?
How will the clinical development strategy for KT-485 differentiate it from other IRAK4 inhibitors currently in the market or late-stage trials?
What specific regulatory milestones must be achieved to trigger the next tranche of the $975 million in potential payments from Sanofi?
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