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Thiogenesis Initiates Phase 2 Clinical Trial in Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like Episodes ("MELAS")
San Diego, California--(Newsfile Corp. - May 14, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: ...
About this update from Thiogenesis Therapeutics Corp
[{"type":"text","content":"Thiogenesis Initiates Phase 2 Clinical Trial in Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like Episodes (\"MELAS\")San Diego, California--(Newsfile Corp. - May 14, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) (\"Thiogenesis\" or the \"Company\") a clinical-stage biotechnology company developing disulfides that drive the production of critically important intracellular antioxidants and other therapeutic compounds, today announced that it has dosed its first two patients in its Phase 2 clinical trial of TTI-0102, Thiogenesis' lead product candidate for the potential treatment of the inherited mitochondrial disease MELAS. The first two patients were dosed on May 12th, at the Radboud University Medical Center in Nijmegen, Netherlands, where the Phase 2 clinical trial has been activated and is currently screening and recruiting patients. The Company's Phase 2 MELAS clinical trial is a multi-country, multi-center trial that will be conducted at leading institutions in the Netherlands and France. The trial is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, and pharmacokinetics / pharmacodynamics of oral TTI-0102 for the treatment of patients with MELAS over a 6-month period. The trial will enroll a total of 12 patients, 8 patients will receive TTI-0102, and 4 patients will receive placebo. After 3 months, there will be an interim analysis of safety and clinical efficacy.The significant clinical endpoints being assessed in the clinical trial will include:A 12-Minute Walking Test (\"12-MWT\")Fatigue Severity Scale (\"FSS\")Quality of Life Assessment (\"WHOQOL-BREF\")\"The dosing of the first two patients in our Phase 2 clinical trial is the culmination of a lot of planning and dedicated work from the Thiogenesis team and a major milestone for an emerging biotech company,\" said Patrice Rioux, MD, Ph.D., Chief Executive Officer of Thiogenesis. \"We are excited to test our lead product candidate TTI-0102 in MELAS, and bring a potential treatment to one of the most prevalent and debilitating of the inherited mitochondrial diseases for which there are no approved drugs in the EU or the U.S. TTI-0102 is a precursor to the thiol cysteamine and has been engineered to be well-tolerated and to intracellularly increase the antioxidant glutathione and the...