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Gain Therapeutics, Inc. (NASDAQ: GANX) is a pioneering biotechnology company committed to the discovery and development of novel small molecule therapeutics. Specializing in addressing rare genetic diseases, Gain Therapeutics focuses on orphan diseases caused by inborn errors of metabolism. With a strong emphasis on lysosomal storage disorders, central nervous system disorders, metabolic disorders, and oncology, the company's innovative approach aims to provide solutions where there is a high unmet medical need.
At the forefront of Gain Therapeutics' pipeline is GT-02287, a promising clinical-stage product candidate targeting GBA1 Parkinson's disease. Currently in Phase 1 clinical trials, GT-02287 is designed to be a disease-modifying treatment. It functions as an allosteric protein modulator to restore the activity of the lysosomal enzyme glucocerebrosidase (GCase), tackling the underlying cause of disease rather than just alleviating symptoms.
The company's proprietary Magellan™ platform leverages AI-supported structural biology and advanced algorithms to discover novel allosteric binding sites on disease-implicated proteins. This innovative computational technology identifies potential small molecules that can bind to these sites, offering new avenues for therapeutic development. Magellan builds upon Gain’s original SEE-Tx® platform, enhancing it with AI and virtual screening capabilities to explore vast chemical spaces.
Recent achievements highlight Gain Therapeutics' impact on the biotech landscape. Data presented at the 20th WORLDSymposium™ showcased the progressive reversal of motor deficits in preclinical models, alongside a significant reduction of neurodegeneration biomarkers. This underscores the potential of GT-02287 as a best-in-class treatment for neurodegenerative diseases.
Gain Therapeutics collaborates with notable organizations including The Michael J. Fox Foundation for Parkinson’s Research and The Silverstein Foundation for Parkinson’s with GBA. These partnerships provide essential support and validation for the company's mission to transform therapeutic landscapes with innovative treatments.
For more information, visit GainTherapeutics.com and follow their updates on LinkedIn.
Gain Therapeutics presented Phase 1 data for GT-02287, its lead drug candidate for Parkinson's disease, at the International Congress of Parkinson's Disease and Movement Disorders. The study demonstrated that GT-02287 was safe and well-tolerated in healthy volunteers, with no serious adverse events. Notably, the drug increased GCase activity by approximately 30% in subjects who received GT-02287, indicating target engagement. The drug also showed CNS exposure, with measurable levels in cerebrospinal fluid.
The company plans to initiate a trial in Parkinson's disease patients by the end of Q4 2024, aiming to demonstrate safety, tolerability, and obtain proof of mechanism based on relevant biomarkers. Gain Therapeutics remains optimistic about GT-02287's potential as a disease-modifying treatment for Parkinson's disease.
Gain Therapeutics (Nasdaq: GANX) announced a virtual webinar on September 30, 2024, at 8:30 am ET to discuss results from the Phase 1 study of GT-02287, their novel GCase-targeting small molecule therapy for Parkinson's disease. The company will present positive results recently shared at the International Congress of Parkinson's Disease and Movement Disorders® (MDS) and outline the design of an upcoming Phase 1b trial in Parkinson's disease patients.
The webinar will include a live Q&A session following formal presentations. Interested parties can register for the event or join via the company's website. A replay will be available in the News and Events section of the Gain Therapeutics website after the event.
Gain Therapeutics (Nasdaq: GANX) announced three presentations at Neuroscience 2024, showcasing preclinical data for GT-02287, their lead drug candidate for Parkinson's disease. The event will be held in Chicago from October 5-9, 2024.
Two late-breaking posters will be presented:
- GT-02287's prevention of Tau accumulation in a cellular model
- GT-02287's disease-modifying capacity in both GBA1 and idiopathic Parkinson's disease models
A third presentation will focus on GT-02287's improvement of mitochondrial function and neuroprotective effects in GBA1-Parkinson's disease models. These studies were conducted in collaboration with researchers from Switzerland, supported by an Innosuisse-Swiss Innovation Agency grant.
Gain Therapeutics (Nasdaq: GANX), a clinical-stage biotech company focused on developing next-generation allosteric small molecule therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024.
Gene Mack, Interim CEO and CFO, and Dr. Jonas Hannestad, Chief Medical Officer, will represent Gain Therapeutics at the conference. They will deliver a corporate presentation and engage in one-on-one meetings with potential investors and partners.
This participation provides Gain Therapeutics with an opportunity to showcase its innovative approach to drug discovery and development, potentially attracting investor interest and fostering new collaborations in the biotechnology sector.
Gain Therapeutics (Nasdaq: GANX) has announced positive topline results from its Phase 1 clinical trial of GT-02287, a novel GCase-targeting small molecule therapy for Parkinson's disease. The study, which enrolled 72 healthy volunteers, demonstrated that GT-02287 was safe and well-tolerated at all dose levels, with no discontinuations or serious adverse events reported. Importantly, the drug showed presence in the cerebrospinal fluid and achieved peripheral target engagement.
Based on these promising results, Gain plans to initiate a Phase 1b trial in Parkinson's disease patients by Q4 2024, with data expected by mid-2025. The company aims to demonstrate safety, tolerability, and proof of mechanism through relevant biomarkers in this upcoming trial.
Gain Therapeutics (NASDAQ: GANX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Completion of dosing in the Multiple Ascending Dose (MAD) portion of the Phase 1 trial for GT-02287, their lead candidate for Parkinson's disease.
2. Positive results from the Single Ascending Dose (SAD) portion of the Phase 1 trial.
3. Topline results from the MAD study expected in August 2024.
4. Initiation of a Phase 1b study in Parkinson's disease patients anticipated in Q4 2024.
5. Q2 2024 financial results: R&D expenses increased to $4.4 million, G&A expenses remained at $3.7 million, and net loss was $0.42 per share.
6. Cash position of $16.9 million as of June 30, 2024.
Gain Therapeutics (Nasdaq: GANX), a clinical-stage biotech company, announced its participation in the BTIG Virtual Biotechnology Conference on August 5-6, 2024. The company's interim-CEO and CFO, Gene Mack, along with Chief Medical Officer, Jonas Hannestad, will engage in a fireside chat and one-on-one meetings during the event.
Key details:
- Fireside chat scheduled for August 6, 2024, at 4:00pm ET
- Interested parties can arrange meetings through their BTIG representative
- An archived replay of the fireside chat will be available on the company's website
Gain Therapeutics specializes in developing next-generation allosteric small molecule therapies, positioning itself at the forefront of innovative biotechnology research and development.
Gain Therapeutics announced the completion of dosing in the Multiple Ascending Dose (MAD) part of their Phase 1 study for GT-02287, a novel small molecule therapy for Parkinson's Disease. Conducted without any serious adverse events or discontinuations, the study indicates that GT-02287 is well-tolerated. The topline data from this randomized, double-blind, placebo-controlled study is expected in mid-August 2024, with full safety analysis and plasma pharmacokinetics to be presented later. The company aims to initiate trials in Parkinson’s disease patients by Q4 2024. The MAD phase, begun in February 2024, involved 32 healthy volunteers completing 14 days of daily oral doses. The completion of the Single Ascending Dose (SAD) part in April 2024 also reported no serious adverse events. Preclinical data shows GT-02287 effectively restores the function of the enzyme glucocerebrosidase, which is linked to Parkinson’s disease due to GBA1 gene mutations.
Gain Therapeutics (Nasdaq: GANX) has announced a business update conference call scheduled for July 1, 2024, at 8:30am ET, hosted by interim-CEO and current CFO Gene Mack. This call will provide a corporate update and can be accessed via the company's website. A recorded version and transcript will be available on the site within 24 hours post-event.
Gain Therapeutics (NASDAQ: GANX) has announced the appointment of Gene Mack as interim CEO following the departure of Matthias Alder, effective June 25, 2024. Mack will also retain his role as CFO. Khalid Islam, founder and Chairman, will serve as Executive Chairman during the transition. Alder contributed significantly to the company's progress, particularly advancing GT-02287 into clinical development, which recently showed promising preclinical results for improving cognitive performance in GBA1 Parkinson's disease models. The company remains focused on the continued development of GT-02287.
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