Fresh Tracks Therapeutics Evaluating Strategic Options To Further Develop Its Lead Product

Fresh Tracks Therapeutics Inc FRTX announced topline results from the single ascending dose (SAD) and multiple ascending dose (MAD) parts of its Phase 1 trial of FRTX-02 in healthy subjects.
FRTX-02 is a DYRK1A inhibitor that aims to restore immune balance by modulating adaptive and innate immune responses in patients with autoimmune and inflammatory diseases.
The company approved a comprehensive process to explore and evaluate strategic options to progress the development of its novel pipeline.
FRTX-02 was generally safe and well-tolerated in all seven SAD cohorts and the 75 mg and 150 mg MAD cohorts, with no discontinuations due to Treatment-Emergent Adverse Events.
PK data from the 75 mg and 150 mg MAD cohorts achieved maximum plasma concentrations (Cmax) and area under the concentration-time curve (AUC) values. The PK data support once-daily oral dosing with FRTX-02.
Plasma concentrations within the potential therapeutic dose range were consistent with efficacious exposure levels in nonclinical disease models.
Reduction in disease-relevant cytokines was observed in exploratory ex-vivo LPS-stimulated whole-blood pharmacodynamic assays.
Price Action: FRTX shares are up 55.7% during the premarket session on the last check Wednesday.