Fresh Tracks announces results for dose parts of FRTX-02 study

Fresh Tracks Therapeutics announced positive topline results from the single ascending dose and multiple ascending dose 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."The results from Part 1 of the first-in-human Phase 1 study demonstrate the potential of FRTX-02 as a generally safe and well-tolerated, once-daily oral treatment for a broad range of autoimmune and inflammatory diseases," commented Andy Sklawer, President and Chief Executive Officer of Fresh Tracks. "This clinical trial marks the first time an oral DYRK1A inhibitor intended for patients with autoimmune diseases has entered the clinic, and these topline SAD and MAD data reinforce our enthusiasm for the continued development of FRTX-02 as a potential first-in-class therapy. However, to fully unlock the potential of the Company’s pipeline considering our current capital resources, we have determined it is prudent for us to initiate a comprehensive review of strategic options with the goal of maximizing shareholder value as we look to advance the clinical development of FRTX-02 and progress our earlier-stage assets." Dr. Bernard Khor, MD, PhD, Principal Investigator and Assistant Member at the Benaroya Research Institute for Translational Medicine and Affiliated Assistant Professor at the University of Washington, added, "I am encouraged by the results from the FRTX-02 Phase 1 SAD and MAD clinical study. These safety, pharmacokinetics and exploratory pharmacodynamics ("PD") data expand our understanding of DYRK1A’s potential as a promising, novel target with potential clinical utility that could have disease modifying effects in autoimmunity and inflammation. Furthermore, the results from this trial mark an important step forward for inhibition of the historically undruggable DYRK1A target and highlight the potential of FRTX-02 as a first-in-class, once-daily oral autoimmune therapy. I look forward to participating in the continued development of FRTX-02."