{"id":825826,"date":"2025-03-14T07:48:04","date_gmt":"2025-03-14T11:48:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/"},"modified":"2025-03-14T07:48:04","modified_gmt":"2025-03-14T11:48:04","slug":"gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/","title":{"rendered":"Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease"},"content":{"rendered":"<h2>\nInterim Analysis Expected End of 2Q 2025<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p>BETHESDA, Md., March  14, 2025  (GLOBE NEWSWIRE) &#8212; 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 dosing of the first participant with Parkinson\u2019s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company\u2019s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.<\/p>\n<p>\u201cInitiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain\u2019s mission to deliver a disease-modifying therapy to people with Parkinson\u2019s disease. We look forward to continued enrollment and anticipate an interim analysis from the towards the end of 2Q 2025,\u201d said Gene Mack, President and CEO of Gain Therapeutics.<\/p>\n<p>The Phase 1b open-label, multi-center trial is designed to evaluate the safety and tolerability of GT-02287 in people with GBA1-PD and idiopathic PD. Secondary endpoints include pharmacokinetics, GCase modulation, levels of GCase substrates, and other biomarkers in plasma and cerebrospinal fluid. The trial will enroll up to 20 participants who will receive GT-02287 daily for three months. Interim data from the Phase 1b trial are anticipated at the end of 2Q 2025.<\/p>\n<p>The Phase 1b trial follows Gain\u2019s successful Phase 1 study in healthy volunteers completed during Q3 2024, in which GT-02287 demonstrated a favorable safety and tolerability profile as well as plasma and CNS exposures in the projected therapeutic range. Importantly, the Phase 1 study also showed significant target engagement of GT-02287 demonstrated by a statistically significant increase in glucocerebrosidase (GCase) activity that was &gt;50%.<\/p>\n<p>For more information on the Phase 1b clinical trial, visit: https:\/\/clinicaltrials.gov\/study\/NCT06732180<\/p>\n<p>\n        <strong>About GT-02287<\/strong><br \/>\n        <br \/>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 enzyme modulator that restores the function of the lysosomal 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 of neurodegeneration.<\/p>\n<p>Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson\u2019s disease.<\/p>\n<p>Gain\u2019s lead program in Parkinson\u2019s disease has been awarded funding support early in its development 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<p>\n        <strong>About Gain Therapeutics, Inc.<\/strong><br \/>\n        <br \/>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<p>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<p>\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>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<p>\n        <strong>Investor Contacts:<\/strong><br \/>\n        <br \/>Apaar Jammu and Chuck Padala<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gWZat0eVXXwuCUkXM53YZnLoBUKX5vh1L5KtfgJjryhtxXxI1tVMT6TxWdrPe2Zteyf277MKIqh078854oSboBCAMl11Qr0gwYGVsMFzXlmICTDyAZkb1OMW6Jq7JxoKWfxiOmawPOmaA3ME3xrXot1S2bcTWgheibtCLoU8kxv_27uP4-w5yb61nJr_cpk3I3sJU_OnxTLtbxVNmJYEcX4CktYEykiXm6BvDXg9-Y3WaTMqa7LfSspXG_UezDKXTAp3-LY8ph3DeUJyl9AKF8cizybdgPrfePTHCKDdkIsUwR7Q8Okzzyx27YmQsyPK\" rel=\"nofollow\" target=\"_blank\">ajammu@gaintherapeutics.com<\/a><br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Du19-nheD5mnLx6xJdDjVUopanG-eJE02xfed5qZo2owyYN2y0FKEhvpO9qRHbKFqrPO_imsnDzKUp9cws_cL30QhqvAIWqf3BACjYRGK0vOJ6TA3yCFDNRr_jC7w2x1SiyYogkm5gxE_6BwwkqjtUQrfFpHhg9P8xolPhS7uj8u9WvCAskUkywheLB9uhT9hSFt3dssHhJuTAONuM_y6cxjZv6NtX2pV8NN4mewUcmdiRXmRAQTg3bXgNk95czjaTp8humK7OmGqnIh4E7tQCAeZmK-b1qRxzTc8-0whTY=\" rel=\"nofollow\" target=\"_blank\">chuck@lifesciadvisors.com<\/a><\/p>\n<p>\n        <strong>Media Contacts:<\/strong><br \/>\n        <br \/>Russo Partners<br \/>Nic Johnson and Elio Ambrosio<br \/>nic.johnson@russopartnersllc.com<br \/>elio.ambrosio@russopartnersllc.com<br \/>(760) 846-9256<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5NDQ3NCM2ODA2MTgwIzIyMDkwMzA=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NjUyYmM5ZjEtODNmMC00NjYzLWJmN2EtZGRhM2UxODk3ZTFmLTEyMjA1ODMtMjAyNS0wMy0xNC1lbg==\/tiny\/Gain-Therapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Interim Analysis Expected End of 2Q 2025 BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) &#8212; 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 dosing of the first participant with Parkinson\u2019s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company\u2019s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation. \u201cInitiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain\u2019s mission to deliver a disease-modifying therapy to people with Parkinson\u2019s disease. We look forward to continued enrollment &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease&#8221;<\/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-825826","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease - 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-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Interim Analysis Expected End of 2Q 2025 BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) &#8212; 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 dosing of the first participant with Parkinson\u2019s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company\u2019s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation. \u201cInitiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain\u2019s mission to deliver a disease-modifying therapy to people with Parkinson\u2019s disease. 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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 dosing of the first participant with Parkinson\u2019s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company\u2019s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation. \u201cInitiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain\u2019s mission to deliver a disease-modifying therapy to people with Parkinson\u2019s disease. We look forward to continued enrollment &hellip; Continue reading \"Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/","og_site_name":"Market Newsdesk","article_published_time":"2025-03-14T11:48:04+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5NDQ3NCM2ODA2MTgwIzIyMDkwMzA=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease","datePublished":"2025-03-14T11:48:04+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/"},"wordCount":967,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5NDQ3NCM2ODA2MTgwIzIyMDkwMzA=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/gain-therapeutics-doses-first-participant-in-phase-1b-clinical-trial-of-gt-02287-in-parkinsons-disease\/","name":"Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson\u2019s Disease - 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