Gain Therapeutics Receives FDA Approval for GT-02287 IND Application

Gain Therapeutics announced that the FDA has authorized the company's investigational new drug, or IND, application for GT-02287. The FDA's decision will allow initiation of the company's Phase 2 clinical development of GT-02287 in Parkinson's disease with or without a GBA1 mutation in the U.S. Both the Phase 1a and Phase 1b studies of GT-02287 were conducted in Australia. The sites in Australia are expected to also participate in the Phase 2 study along with new sites in the U.S. and select European centers. "We appreciate the FDA's guidance throughout the IND review process and look forward to initiating our Phase 2 study, which is anticipated to occur during 3Q26," said Gene Mack, president and CEO of Gain Therapeutics. "In clinical studies to date, GT-02287 demonstrated target engagement with favorable safety and tolerability. Additionally, recent feedback from trial participants across different clinical sites included anecdotal reports of improvements in smell and taste, balance or gait, and sleep. The FDA's decision is a significant milestone for Gain and we believe it validates the extensive preclinical and clinical work supporting further development of GT-02287. We believe GT-02287 represents the next generation of differentiated therapeutics designed to address the underlying biology of Parkinson's disease and move beyond symptomatic relief to create a new backbone of treatment that can slow or stop disease progression," concluded Mack.