Core Viewpoint - Gain Therapeutics has received approval to initiate a Phase 1b clinical trial for GT-02287 in Australia, aimed at assessing safety and tolerability in patients with Parkinson's disease [1][3] Group 1: Clinical Trial Details - The Phase 1b trial will evaluate the safety and tolerability of GT-02287 at a dosage of 13.5 mg/kg/day over three months [4] - Enrollment is expected to be completed by spring 2025, with data anticipated by mid-2025 [1][4] - The trial will involve seven sites across major metropolitan areas in Australia, focusing on participants with GBA1-PD or idiopathic Parkinson's disease [4] Group 2: Previous Study Results - The Phase 1 study in healthy volunteers, completed in Q3 2024, demonstrated a favorable safety profile and significant target engagement with a greater than 50% increase in glucocerebrosidase (GCase) activity [2][8] - GT-02287 showed plasma and CNS exposures within the projected therapeutic range during the Phase 1 study [2][8] Group 3: Drug Candidate Information - GT-02287 is an orally administered, brain-penetrant small molecule that acts as an allosteric protein modulator, restoring the function of the GCase enzyme [5][8] - Preclinical models indicated that GT-02287 could restore GCase function, reduce neuroinflammation, and improve motor and cognitive performance [5][6] Group 4: Funding and Support - Gain Therapeutics has received funding support from The Michael J. Fox Foundation for Parkinson's Research, The Silverstein Foundation, and the Eurostars-2 joint program [7]

Core Insights - Gain Therapeutics has received approval to initiate a Phase 1b clinical trial for GT-02287 in Australia, targeting individuals diagnosed with Parkinson's disease [1][9] - The trial aims to assess the safety and tolerability of GT-02287 over three months, with enrollment expected to complete by spring 2025 and data anticipated by mid-2025 [1][2][10] - GT-02287 is designed to treat Parkinson's disease with or without a GBA1 mutation and has shown promising preclinical data indicating a potential to slow or stop disease progression [4][11] Company Developments - The transition from preclinical to clinical stage development was marked by the successful completion of healthy volunteer studies in 2024 [2] - The Phase 1 study demonstrated a favorable safety profile and significant target engagement, with over 50% increase in glucocerebrosidase (GCase) activity [9][13] - Gain Therapeutics is preparing for a Phase 2 trial in 2025, contingent on the results of the Phase 1b trial [2][10] Clinical Trial Details - The Phase 1b trial will be conducted at seven sites across major metropolitan areas in Australia, focusing on patients with GBA1-PD or idiopathic Parkinson's disease [10] - The trial will administer 13.5 mg/kg/day of GT-02287 and will evaluate secondary endpoints including pharmacokinetics and biomarker levels in plasma and cerebrospinal fluid [10][11] - The study is supported by funding from The Michael J. Fox Foundation and other organizations [12]

BETHESDA, Md., Dec. 11, 2024 (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 that Gene Mack, Chief Financial Officer and Interim Chief Executive Officer of Gain, will give a corporate presentation at Biotech Showcase 2025, being held January 13-15, 2025, at the Hilton San Francisco Union Square in San Francisco, CA. ...

BETHESDA, Md., Oct. 03, 2024 (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 that Gene Mack, interim Chief Executive Officer and current Chief Financial Officer of Gain, will participate in two upcoming investor conferences: 3rd Annual ROTH Healthcare Opportunities Conference on Wednesday, October 9. Gene Mack will ...

Core Insights - Gain Therapeutics, Inc. is advancing its lead drug candidate GT-02287 for Parkinson's disease, with presentations scheduled at Neuroscience 2024 showcasing preclinical data [1][5] Group 1: Drug Candidate Information - GT-02287 is an allosteric protein modulator that targets the lysosomal enzyme glucocerebrosidase (GCase), which is affected by GBA1 mutations, a common genetic factor in Parkinson's disease [4] - Preclinical studies indicate that GT-02287 restores GCase function, reduces neuroinflammation, and improves motor and cognitive functions in Parkinson's disease models [4][5] - The drug has shown potential to slow disease progression, with significant improvements in cognitive and motor performance in mouse models [5] Group 2: Presentation Details - Two late-breaking poster presentations will occur on October 6, 2024, focusing on GT-02287's effects on Tau accumulation and mitochondrial function in Parkinson's disease models [2][3] - The presentations will be part of the Society for Neuroscience's annual event, highlighting the significance of the findings [1] Group 3: Funding and Support - Gain Therapeutics has received funding from The Michael J. Fox Foundation and The Silverstein Foundation, as well as support from the Eurostars-2 program and the European Union Horizon 2020 research initiative [6] Group 4: Company Overview - Gain Therapeutics is a clinical-stage biotechnology company specializing in the discovery of next-generation allosteric therapies, with GT-02287 currently in Phase 1 clinical trials [7] - The company utilizes an advanced drug discovery platform, Magellan™, which employs AI and machine learning to identify novel allosteric binding sites for drug development [8][9]

Results Include Safety, Tolerability, Pharmacokinetics, and Target Engagement GT-02287, in Development for GBA1 Parkinson's Disease, on Track to Initiate Phase 1b Trial in Patients in Q4 2024 BETHESDA, Md., Aug. 29, 2024 (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, announces positive results from the Phase 1 study conducted to e ...

Topline Results From MAD Phase 1 Study of GT-02287 on Track for August 2024 With Full Presentation at Upcoming Medical Conferences in Early Q4 2024 Initiation of Phase 1b Study of GT-02287 in Parkinson's Disease Patients Anticipated in Q4 2024 BETHESDA, Md., Aug. 08, 2024 (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 report ...

GT-02287 Well Tolerated With No Serious Adverse Events or Other Safety Signals Reported BETHESDA, Md., July 09, 2024 (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, announces the last healthy subject in the multiple ascending dose (MAD) part of its Phase 1 study has completed the highest planned dose levels. No discontinuations or ...

GT-02287 Well Tolerated With No Serious Adverse Events or Other Safety Signals Reported Additional Topline Data To Be Presented Mid-August GT-02287 on Track To Initiate Clinical Trial in Parkinson's Disease Patients in Q4 2024 BETHESDA, Md., July 09, 2024 (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, announces the last healthy sub ...

Investors might want to bet on Gain Therapeutics, Inc. (GANX) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The power of a changing earnings picture in determining near-term stock price movements makes the Zacks rating system highly useful for individual investors, since it can be difficult to make decisions based on rating upgrades by Wall Street analys ...