Gain Therapeutics, Inc. (GANX), a clinical-stage biotechnology company, announced Thursday positive results from the Phase 1 study conducted to evaluate the safety, tolerability and pharmacokinetics of GT-02287, a novel GCase-targeting small molecule therapy for Parkinson's Disease.
The company previously announced that no discontinuations or serious adverse events were reported when the study concluded.
Gain Therapeutics' lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson's disease with or without a GBA1 mutation.
The Phase 1 study enrolled 72 healthy volunteers, males and females, up to the age of 64 years. According to the firm, review of unblinded data after database lock confirmed that single and multiple doses of GT-02287 were safe and generally well tolerated up to and including the highest planned dose levels across all age groups.
GT-02287 was present in the cerebrospinal fluid or CSF and peripheral target engagement was demonstrated.
Jonas Hannestad, Chief Medical Officer of Gain, said, "On the heels of this data, we expect to initiate a trial in people with Parkinson's disease by Q4 2024 with the goal of demonstrating safety and tolerability in patients with Parkinson disease and to obtain proof of mechanism based on relevant biomarkers. We anticipate having data from Parkinson's disease patients by mid-point 2025."
On Nasdaq, Gain Therapeutics shares were trading at $1.20, down 9.8 percent.
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