Gain Therapeutics’ CEO Matthias Alder Issues Letter to Shareholders and Provides Operational Update

BETHESDA, Md., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain,” or the “Company”), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today releases the following letter to stockholders from its President and Chief Executive Officer Matthias Alder.

Dear Fellow Stockholders,

With the start of a new year, I want to take a moment to reflect on Gain’s progress over the last 12 months and to share our strategy and plans for 2024.

Research and development of pharmaceutical products for the treatment of neurodegenerative diseases has seen tremendous progress in recent years, with the approval of new drugs for the treatment of Alzheimer’s disease, multiple sclerosis and ALS. The pharmaceutical industry is taking note as evidenced by the recent acquisition of Cerevel Therapeutics for $8.7 billion by AbbVie, and the acquisition of preclinical-stage Caraway Therapeutics by Merck with an announced deal value of $610 million.

In Parkinson’s disease, the second most common neurodegenerative disease after Alzheimer’s disease, new insights into the root cause of the disease have led to a number of drug candidates advancing in clinical development, but there are no approved therapies available to patients that can slow or stop the progression of the disease. At Gain, we seek to address this high unmet medical need with our clinical-stage lead drug candidate GT-02287, which we believe has disease-modifying potential for the treatment of Parkinson’s disease and other neurodegenerative diseases.

Successful Transition to a Clinical-Stage Biotech Company

In 2023, we advanced GT-02287 through preclinical development and initiated the company’s first clinical trial in September 2023 on time and on plan. The Phase 1 clinical trial is a single center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety and tolerability of GT-02287 administered orally in healthy adults. The dose escalation of the SAD phase is underway, and the MAD phase of the study is expected to begin in Q1 2024. The SAD/MAD part of the Phase 1 clinical trial is expected to be completed by mid-2024 with results expected to be reported in the second half of the year.