“The third quarter of 2024 marked substantial progress for Gain and the development of GT-02287, our lead candidate for the treatment of Parkinson’s disease in patients with or without the GBA1 mutation. Data from our Phase 1 study for GT-02287 presented recently at both the International Congress of Parkinson’s Disease and Movement Disorders and the Michael J Fox Foundation Annual Parkinson’s Disease Therapeutics Conference demonstrated target engagement with a 53% increase in GCase activity along with favorable safety and tolerability in healthy volunteers. We believe these outcomes derisk the upcoming Phase 1b study in patients with Parkinson’s disease, which remains on track to initiate before year end 2024. We also submitted the pre-IND package for our upcoming meeting with the FDA scheduled before year end to facilitate the Phase 2 expansion of our clinical development plans for GT-02287 in 2025, moving us significantly closer to developing the first disease-modifying therapy for patients with Parkinson’s disease,” said Gene Mack, Interim CEO and CFO of Gain Therapeutics (GANX).
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