Fresh Tracks Therapeutics, Inc. announced that it has initiated the multiple ascending dose (“MAD”) portion of the ongoing Phase 1 clinical trial in Canada evaluating FRTX-02, the Company's lead drug candidate, in healthy adult 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. The first-in-human Phase 1 trial of FRTX-02 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (“PK”), and pharmacodynamics (“PD”) of FRTX-02 capsules in both healthy adult subjects and patients with atopic dermatitis (“AD”).

Part 1A of the study is a single ascending dose (“SAD”) assessment, which will enroll a total of 56 healthy volunteers in one of seven cohorts, each of which includes six subjects receiving a single dose of FRTX-02 and two subjects receiving a placebo. Part 1B of the study is a MAD assessment of FRTX-02 or placebo in healthy adult subjects. In the MAD assessment, 33 healthy volunteers will be enrolled in one of three cohorts made up of 11 subjects each, and the cohorts will include nine subjects who will receive FRTX-02 and two subjects who will receive a placebo, in each case once-daily for 14 days.

After completing Part 1, the Company intends to initiate Part 2 of the study, which will compare FRTX-02 to placebo in patients with moderate-to-severe AD over 28 days of treatment and will also include a preliminary assessment of efficacy. The ongoing Phase 1 study of FRTX-02 marks the first time a DYRK1A inhibitor intended for patients with autoimmune diseases has been administered in humans. Additional information on this clinical trial can be found on www.clinicaltrials.gov under identifier NCT05382819.