Fresh Tracks Therapeutics, Inc. announced positive topline results from the single ascending dose (SAD) and multiple ascending dose (MAD) parts of its Phase 1 clinical trial evaluating FRTX-02 in healthy subjects. FRTX-02 is a potent, highly selective, and orally bioavailable potential first-in-class DYRK1A inhibitor that aims to restore immune balance by modulating both adaptive and innate immune responses in patients with autoimmune and inflammatory diseases. In parallel, the Company’s Board of Directors approved a comprehensive process to explore and evaluate strategic options to progress the development of its novel pipeline to maximize shareholder value.

Study Design: The Phase 1 clinical trial of FRTX-02 is a two-part, randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, PK, and PD of FRTX-02 capsules in both healthy subjects and patients with atopic dermatitis (AD). Part 1A of the study was a SAD assessment, which enrolled a total of 56 healthy subjects across seven cohorts (single oral dose of 10 to 600 mg FRTX-02 or placebo). Part 1B of the study was a MAD assessment, which enrolled a total of 33 healthy subjects across three cohorts (75, 150 and 300 mg FRTX-02 or placebo, once-daily for 14 days).

With Part 1 of the Phase 1 clinical trial completed, the Company intends to progress to Part 2 of the study, which will compare once-daily oral doses of FRTX-02 to placebo in subjects with moderate-to-severe AD and will include an exploratory evaluation of efficacy.