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Thiogenesis Announces Acceptance of Clinical Trial Application - Part I in the EU for MELAS
San Diego, California--(Newsfile Corp. - March 25, 2024) - Thiogenesis Therapeutics, Corp. (TSXV...
About this update from Thiogenesis Therapeutics Corp
[{"type":"text","content":"Thiogenesis Announces Acceptance of Clinical Trial Application - Part I in the EU for MELAS San Diego, California--(Newsfile Corp. - March 25, 2024) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (\"Thiogenesis\" or the \"Company\") a clinical-stage biotechnology company developing disulfides that are precursors to thiol-active compounds and that have the potential to treat unmet pediatric diseases, today announced that the European Medicines Agency (\"EMA\") has accepted its Clinical Trial Application (\"CTA\") Part I - Scientific and Medicinal Product Documentation, for its lead compound TTI-0102, to commence a Phase 2 clinical trial for the treatment of mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (\"MELAS\"). The CTA Part I is the equivalent of an Investigational New Drug application in the US. The Company anticipates initiating its Phase 2 clinical trial in MELAS in the second quarter of 2024 once it receives regulatory acceptance of the CTA Part II - National and Patient Level Documentation, which is in the process of being filed.The Phase 2 clinical trial is a multi-country, multi-center trial that will be conducted in leading institutions in France and the Netherlands. The trial is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of oral TTI-0102 for the treatment of patients with MELAS. The trial will enroll a total of 12 patients, 8 patients will receive TTI-0102 and 4 patients will receive placebo. The primary endpoints of the study are to measure over a 6-month period, i) the \"change in functional capacity\" based on a 12-minute walking test, and ii) additional safety and tolerability endpoints. Secondary endpoints in the trial will measure fatigue, quality of life and a range of biomarkers (including the level of the antioxidant glutathione). \"We are excited to be on the brink of initiating our first Phase 2 clinical trial,\" said Patrice Rioux, MD, Ph.D., Chief Executive Officer of Thiogenesis. \"It will be the first time that TTI-0102, a new chemical entity patented in 2021 in the US and other countries, is going to be tested for efficacy in patients. This comes after a successful study in healthy volunteers confirmed that TTI-0102 is a prodrug of a well characterized and previously approved c...