{"id":798889,"date":"2025-01-08T08:14:39","date_gmt":"2025-01-08T13:14:39","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/"},"modified":"2025-01-08T08:14:39","modified_gmt":"2025-01-08T13:14:39","slug":"gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/","title":{"rendered":"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287"},"content":{"rendered":"
\n

BETHESDA, Md., Jan. 08, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (\u201cGain\u201d, or the \u201cCompany\u201d), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the formation of its Clinical Advisory Board (CAB) to support the continued development of the Company\u2019s lead drug candidate, GT-02287, in Parkinson\u2019s disease. The CAB is composed of leading experts in Parkinson\u2019s disease trial design, genetics, and biomarkers and will work closely with Gain leadership to progress GT-02287 through potential Phase 2 and Phase 3 clinical development.<\/p>\n

\u201cThe formation of Gain\u2019s new Clinical Advisory Board marks a significant strategic step forward for Gain, as GT-02287 advances into Parkinson\u2019s disease patients,\u201d stated Gene Mack, CEO of Gain Therapeutics. \u201cWe are confident that the collective expertise of this Clinical Advisory Board will be invaluable as we strive to deliver a meaningful new treatment option for Parkinson’s disease patients.\u201d<\/p>\n

\n Gain Scientific Advisory Board Members<\/strong>\n <\/p>\n

\n Karl Kieburtz, M.D., M.P.H. <\/strong>is a Professor of Neurology (part time) at the University of Rochester, was the founding Director of the Center of Health & Technology (CHET), and served as the Director of the Clinical and Translational Science Institute and Senior Associate Dean for Clinical Research at the University of Rochester. Dr. Kieburtz also served as the Chair of the Parkinson Study Group Executive Committee and chaired the FDA\u2019s Peripheral and Central Nervous System Advisory Committee. He has been global Principal Investigator for more than 50 multi-center and multi-national NIH, industry, and Foundation sponsored clinical trials, including the large NIH-sponsored NET-PD study. He was elected as a Fellow in the American Association for the Advancement of Sciences in 2014. In 2008, he co-founded Clintrex Research Corporation, now a part of Tox Strategies, which provides scientific and regulatory advisory services to companies developing CNS therapies.\u00a0<\/p>\n

\n Roy Alcalay, M.D., M.S.<\/strong> is Chief of the Movement Disorders Division at Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. He moved from Columbia University where he holds a part-time associate professorship. He obtained his medical degree from Tel Aviv University, his neurology training from the Harvard University residency program at Massachusetts General Hospital and Brigham and Women\u2019s Hospital, and his training in movement disorders at Columbia University. He earned a Master\u2019s degree in biostatistics (patient-oriented research track) from Columbia University. His research focuses on biomarkers and genetics in Parkinson\u2019s disease.\u00a0He is the principal investigator of the Parkinson\u2019s Foundation-funded PD GENEration and a member of The Michael J. Fox Foundation-funded PPMI executive steering committee. His research is funded by the Michael J. Fox Foundation, the Parkinson\u2019s Foundation, and the Silverstein Foundation for Parkinson\u2019s with GBA.<\/p>\n

\n Samuel Broder, M.D.<\/strong> is the former Director of the National Cancer Institute (NCI) where he oversaw the development of numerous anti-cancer therapeutic agents. Dr. Broder helped launch multiple large-scale clinical trials investigating the prevention, diagnosis, and treatment of cancer, and he inaugurated the highly successful Specialized Program of Research Excellence (SPORE). In the 1980s, his laboratory was responsible for developing the first 3 agents approved by FDA specifically to treat HIV (Retrovir\u00ae (AZT), Videx\u00ae (ddI), and HIVID\u00ae (ddC). He joined the Celera Corporation at its founding in 1998, as Chief Medical Officer and Executive VP for Medical Affairs and helped advance the human genome project. His most recent executive position was as SVP, Health Sector at Intrexon Corp. He is the author or co-author of over 340 scientific publications and an inventor on many patents. He has received numerous awards related to his research in cancer and AIDS. He was elected to the National Academy of Medicine in 1993. He graduated from the University of Michigan Medical School in Ann Arbor in 1970, completed an internship and residency in Internal Medicine at Stanford University, and completed subspecialty training in medical oncology at the National Cancer Institute in Bethesda, Maryland.<\/p>\n

\n Wilma\u00a0D.J. Van de Berg, Ph.D.<\/strong> is a senior associate professor, senior translational neuroscientist, and neuroanatomist at the Department of Anatomy and Neurosciences, Amsterdam UMC, Amsterdam. She is the chair of the research section of Clinical Neuroanatomy and Biobanking and a leader in the field of neuropathology, brain biobanking, and biomarker research in Parkinson\u2019s disease. Her research focuses on cellular disease mechanisms underpinning clinical heterogeneity, alpha-synuclein aggregation, and disease progression in Parkinson\u2019s and related neurodegenerative disorders. She leads various initiatives to identify novel biomarkers and therapeutic strategies aiming to slow down or halt disease progression in Parkinson\u2019s disease, including the multicenter longitudinal cohort study \u2018Profiling Parkinson\u2019s\u2019 (ProPARK). In 2021, she co-founded the Dutch Parkinson Scientists association (www.dutchparkinsonscientists.nl<\/a>) to stimulate Parkinson\u2019s research and provide a platform of Parkinson scientists to meet and exchange expertise in the Netherlands. She is the founder and director of the \u2018Normal Aging Brain Collection Amsterdam\u2019 (NABCA;\u00a0www.nabca.eu<\/a>) and is involved in several international collaborative networks, such as \u2018PD-RISK\u2019\u00a0(NRF)), Global Parkinson\u2019s Genetics Consortium (GP2), NEUROCOV, COST \u2018IMMUPARKNET\u2019, EPND, and 4DPD-OMICS.<\/p>\n

\n About GT-02287<\/strong>
\n
Gain Therapeutics\u2019 lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson\u2019s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric protein modulator that restores the function of the lysosomal protein enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated \u03b1-synuclein, neuroinflammation and neuronal death, and improved motor function and cognitive performance. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker for neurodegeneration.<\/p>\n

Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggests that GT-02287 may have the potential to slow or stop the progression of Parkinson\u2019s disease.<\/p>\n

Gain\u2019s lead program in Parkinson\u2019s disease has been awarded funding support from The Michael J. Fox Foundation for Parkinson\u2019s Research (MJFF) and The Silverstein Foundation for Parkinson\u2019s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse \u2013 Swiss Innovation Agency.<\/p>\n

\n About Gain Therapeutics, Inc.<\/strong>
\n
Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain\u2019s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson\u2019s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme.<\/p>\n

Gain\u2019s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan\u2122 platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.<\/p>\n

\n Forward-Looking Statements<\/strong>
\n
This release contains \u201cforward-looking statements\u201d made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as \u201cbelieves,\u201d \u201cexpects,\u201d \u201canticipates,\u201d \u201cintends,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201cshould,\u201d or similar expressions. These forward-looking statements reflect management\u2019s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company\u2019s current or future product candidates including GT-02287; expectations regarding the timing of results from a Phase 1b clinical study for GT-02287; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287; and the potential therapeutic and clinical benefits of the Company\u2019s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company\u2019s business in general, please refer to the Company\u2019s Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended September 30, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.<\/p>\n

\n Investor Contacts:<\/strong>
\n
Apaar Jammu and Chuck Padala
ajammu@gaintherapeutics.com<\/a>
chuck@lifesciadvisors.com<\/a><\/p>\n

\n Media Contacts:<\/strong>
\n
Russo Partners
Nic Johnson and Elio Ambrosio
nic.johnson@russopartnersllc.com
elio.ambrosio@russopartnersllc.com
(760) 846-9256<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

BETHESDA, Md., Jan. 08, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (\u201cGain\u201d, or the \u201cCompany\u201d), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the formation of its Clinical Advisory Board (CAB) to support the continued development of the Company\u2019s lead drug candidate, GT-02287, in Parkinson\u2019s disease. The CAB is composed of leading experts in Parkinson\u2019s disease trial design, genetics, and biomarkers and will work closely with Gain leadership to progress GT-02287 through potential Phase 2 and Phase 3 clinical development. \u201cThe formation of Gain\u2019s new Clinical Advisory Board marks a significant strategic step forward for Gain, as GT-02287 advances into Parkinson\u2019s disease patients,\u201d stated Gene Mack, … <\/p>\n

Continue reading “Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-798889","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nGain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287 - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"BETHESDA, Md., Jan. 08, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (\u201cGain\u201d, or the \u201cCompany\u201d), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the formation of its Clinical Advisory Board (CAB) to support the continued development of the Company\u2019s lead drug candidate, GT-02287, in Parkinson\u2019s disease. The CAB is composed of leading experts in Parkinson\u2019s disease trial design, genetics, and biomarkers and will work closely with Gain leadership to progress GT-02287 through potential Phase 2 and Phase 3 clinical development. \u201cThe formation of Gain\u2019s new Clinical Advisory Board marks a significant strategic step forward for Gain, as GT-02287 advances into Parkinson\u2019s disease patients,\u201d stated Gene Mack, … Continue reading "Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-08T13:14:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyODM4NiM2NjgzODQxIzIyMDkwMzA=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287\",\"datePublished\":\"2025-01-08T13:14:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\\\/\"},\"wordCount\":1505,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTMyODM4NiM2NjgzODQxIzIyMDkwMzA=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\\\/\",\"name\":\"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287 - 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(Nasdaq: GANX) (\u201cGain\u201d, or the \u201cCompany\u201d), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the formation of its Clinical Advisory Board (CAB) to support the continued development of the Company\u2019s lead drug candidate, GT-02287, in Parkinson\u2019s disease. The CAB is composed of leading experts in Parkinson\u2019s disease trial design, genetics, and biomarkers and will work closely with Gain leadership to progress GT-02287 through potential Phase 2 and Phase 3 clinical development. \u201cThe formation of Gain\u2019s new Clinical Advisory Board marks a significant strategic step forward for Gain, as GT-02287 advances into Parkinson\u2019s disease patients,\u201d stated Gene Mack, … Continue reading \"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/","og_site_name":"Market Newsdesk","article_published_time":"2025-01-08T13:14:39+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyODM4NiM2NjgzODQxIzIyMDkwMzA=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287","datePublished":"2025-01-08T13:14:39+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/"},"wordCount":1505,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyODM4NiM2NjgzODQxIzIyMDkwMzA=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-announces-formation-of-clinical-advisory-board-to-support-continued-advancement-of-lead-drug-candidate-gt-02287\/","name":"Gain Therapeutics Announces Formation of Clinical Advisory Board to Support Continued Advancement of Lead Drug Candidate GT-02287 - 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