Business
Gain Therapeutics Announces Second Quarter 2023 Financial Results and Business Update
HREC application submitted; on track to initiate Phase 1 clinical study of GT-02287 this year Acceptance of late breaking abstract for presentation at the
About this update from Gain Therapeutics, Inc.
[{"type":"text","content":"HREC application submitted; on track to initiate Phase 1 clinical study of GT-02287 this year Acceptance of late breaking abstract for presentation at the International Congress of Parkinson’s Disease and Movement Disorders® in Copenhagen, Denmark BETHESDA, Md., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced financial results for the second quarter ended June 30, 2023, and highlighted recent corporate progress. “We are excited to announce the submission of the dossier application to begin Phase 1 clinical trials of GT-02287, our GCase-targeting drug candidate for GBA1 Parkinson’s disease,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics. “GT-02287 has demonstrated positive preclinical results with potential application across a range of neurodegenerative diseases beyond GBA1 Parkinson’s disease. We look forward to commencing the evaluation of the safety of this promising candidate in healthy volunteers in the second half of this year.” Pipeline Updates Submitted dossier to initiate Phase 1 clinical trial in Australia. The preclinical data package that has been submitted to the Human Research Ethics Committee (HREC) demonstrates the safety, efficacy, and tolerability of GT-02287 in preclinical models. The Phase 1 clinical trial, which is expected to commence in H2 2023, will evaluate GT-02287 in healthy volunteers to assess safety and pharmacokinetics, with the goal of identifying an optimal dose level for Phase 1b and Phase 2 trials.Acceptance of a late breaking abstract with new in vivo data on GT-02287 for presentation at the upcoming International Congress of Parkinson's Disease and Movement Disorders® to be held August 27-31, in Copenhagen, Denmark. Upcoming Milestones Initiation of Phase 1 clinical trial of GT-02287 in Australia expected in H2 2023.Presentation of two posters with new in vivo data at the upcoming International Congress of Parkinson's Disease and Movement Disorders® being held August 27-31, in Copenhagen, Denmark. Neuroprotective effect of GT-02287, a brain-penetrant structurally targeted allosteric regulator of glucocerebrosidase, leads to a significant reduction of plasma neurofilament light chain...