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Thiogenesis Receives Final EU Clearance of CTA to Initiate its Phase 2 Clinical Trial in MELAS
San Diego, California--(Newsfile Corp. - January 27, 2025) - Thiogenesis Therapeutics, and Corp....
About this update from Thiogenesis Therapeutics Corp
[{"type":"text","content":"Thiogenesis Receives Final EU Clearance of CTA to Initiate its Phase 2 Clinical Trial in MELASSan Diego, California--(Newsfile Corp. - January 27, 2025) - Thiogenesis Therapeutics, and Corp. (TSXV: TTI) (\"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 the European Medicines Agency (\"EMA\") has accepted its Clinical Trial Application (\"CTA\") Part II - National and Patient Level Documentation, for Thiogenesis' lead compound TTI-0102. It is the final regulatory clearance required for Thiogenesis to commence its Phase 2 clinical trial for the treatment of mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (\"MELAS\"). The Company previously announced that its CTA Part I - Scientific and Medicinal Product Documentation, had been accepted by EMA.Thiogenesis anticipates initiating the Phase 2 clinical trial in MELAS shortly, subject to the activation of the clinical trial sites. The Phase 2 MELAS clinical trial is a multi-country, multi-center trial that will be conducted at leading institutions in France and the Netherlands. The trial is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics / pharmacodynamics and efficacy 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. There will be an interim analysis of safety data, pharmacokinetics / pharmacodynamics and biomarkers (cysteamine, glutathione, taurine etc.) after 3 months.In addition to assessing several significant biomarkers, the efficacy endpoints for the clinical trial are:12-Minute Walking Test (\"12-MWT\")Fatigue Severity Scale (\"FSS\")Quality of Life Assessment (\"WHOQOL-BREF\")\"We are thrilled to be nearing the dosing of a patient with MELAS,\" said Patrice Rioux, MD, Ph.D., Chief Executive Officer of Thiogenesis. \"As a well-tolerated precursor to cysteamine, TTI-0102 is engineered to intracellularly increase the antioxidant glutathione and the amino acid taurine, both of which are well understood to be deficient in MELAS patients. As a result, TTI-0102 has the potenti...