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Gain Therapeutics Announces Presentations at AD/PDTM 2026 and Provides U.S. FDA Regulatory Update
Interim analysis of Phase 1b clinical study of GT-02287, including biomarker and clinical endpoints, will be presented in oral symposium Company remains on
About this update from Gain Therapeutics, Inc.
[{"type":"text","content":"Interim analysis of Phase 1b clinical study of GT-02287, including biomarker and clinical endpoints, will be presented in oral symposium Company remains on track to initiate Phase 2 clinical trial of GT-02287 in 3Q26 after submitting additional preclinical data requested by FDA in support of an IND BETHESDA, Md., March 12, 2026 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced presentations at the AD/PD ™ 2026 International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders, being held March 17-21, 2026 in Copenhagen, Denmark. The Company also provided an update regarding its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to support a Phase 2 clinical trial of GT-02287, the Company’s lead drug candidate in clinical development for the treatment of Parkinson’s disease (PD). Details of the AD/PD oral presentation are as follows: Presentation Title: An Open-Label Phase 1b Study of GT-02287 in Parkinson’s Disease Presenter: Jonas Hannestad, M.D., Ph.D., Chief Medical Officer Session Name: Modulating Neuroinflammation, α-Synuclein, LRRK2, And Dopaminergic Repair: Early Human Data Date: March 18, 2026 Time: 3:15-3:30pm CET Room: Hall 180-181 Details of the AD/PD poster presentations are as follows: Poster Title: Novel Allosteric GCase Modulators, Different From the Clinical Stage GT-02287, for the Treatment of Parkinson’s Disease Presenting Author: Ana Maria Garcia-Collazo, Ph.D., Head of Research Poster Number: SHIFT 02-178 Dr. Hannestad will present data on GT-02287 demonstrating CNS target engagement, beneficial effects on downstream pathway abnormalities, early signs of clinical improvement in patients, and additional data from the extension phase of the study. Dr. Garcia-Colazzo will present data on a novel glucocerebrosidase (GCase) modulator which is chemically distinct from GT-02287 with promising pre-clinical data in Parkinson’s disease models. Regulatory Update on GT-02287 The Company submitted an IND to conduct a placebo-controlled, dose-range-finding Phase 2 clinical trial of GT-02287 in the United States. In March 2026, the Company submitted a response to...