IGC Pharma presents genetic toxicology safety data on IGC-AD1

IGC Pharma (IGC) presented its latest scientific poster, titled “Genetic Toxicity Evaluation of Melatonin in the Bacterial Reverse Mutation Assay,” at the 2025 Genetic Toxicology Association Annual Meeting, showcasing key non-clinical data that support the genetic safety profile of one of the two active pharmaceutical ingredients in IGC-AD1, the Company’s investigational drug for Alzheimer’s disease. Part of the FDA’s battery of safety requirements is to show that APIs are safe for human consumption, including that they do not alter or mutate genes. IGC completed this requirement and is now able to show that the APIs in IGC-AD1 are safe and do not alter genes. This GLP-compliant study, conducted by an independent lab in Canada, evaluated the API’s mutagenic potential using the Bacterial Reverse Mutation Test, as part of a broader genetic toxicology battery. The study assessed multiple bacterial strains both in the presence and absence of an exogenous mammalian metabolic activation system, as per OECD Guideline 471 and ICH S2(R1) recommendations. At various concentrations ranging from 1.6 to 5000 microgram/plate, no evidence of mutagenicity was observed at any dose level. Across all strains and experimental conditions, Fold Response values remained below 2-the established threshold for mutagenic activity. Revertant colony counts remained within the range of the negative controls and substantially lower than the positive controls, confirming assay validity. Additionally, statistical analysis using Dunnett’s test showed no significant dose-related increases, reinforcing the conclusion that the API does not induce gene mutations under the tested conditions.