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.
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