Biotechnology company Gain Therapeutics, member of CATALONIA.HEALTH, announce the dosing of the first participant with Parkinson’s disease in its Phase 1b clinical trial of GT-02287, the company’s lead allosteric small molecule in development for the treatment of Parkinson disease with or without a GBA1 mutation.
The Phase 1b open-label, multi-centre trial is designed to evaluate the safety and tolerability of GT-02287 in people with GBA1-PD and idiopathic Parkinson disease. Secondary endpoints include pharmacokinetics, GCase modulation, levels of GCase substrates, and other biomarkers in plasma and cerebrospinal fluid. The trial will enrol up to 20 participants who will receive GT-02287 daily for three months. Interim data from the Phase 1b trial are anticipated at the end of 2Q 2025.
The Phase 1b trial follows Gain’s successful Phase 1 study in healthy volunteers completed during Q3 2024, in which GT-02287 demonstrated a favourable safety and tolerability profile as well as plasma and CNS exposures in the projected therapeutic range.
Gene Mack, President and CEO of Gain Therapeutics, mentioned: “Initiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain’s mission to deliver a disease-modifying therapy to people with Parkinson’s disease. We look forward to continued enrolment and anticipate an interim analysis from the towards the end of 2Q 2025”.
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