IGC Pharma Presents Genetic Toxicology Safety Data on API in IGC-AD1, at the 2025 Genetic Toxicology Association Meeting
Rhea-AI Summary
IGC Pharma (NYSE American: IGC) presented key genetic toxicology safety data for one of the active pharmaceutical ingredients (APIs) in IGC-AD1, its investigational Alzheimer's disease drug, at the 2025 Genetic Toxicology Association Annual Meeting. The study, conducted by an independent Canadian lab, evaluated melatonin's mutagenic potential using the Bacterial Reverse Mutation Test (Ames test).
The GLP-compliant study tested multiple bacterial strains at concentrations from 1.6 to 5000 µg/plate. Results showed no evidence of mutagenicity at any dose level, with Fold Response values remaining below the mutagenic activity threshold. This safety milestone supports IGC-AD1's development as the company prepares for larger trials and potential commercialization.
Positive
- Successful completion of FDA-required genetic safety testing for IGC-AD1's API
- Study demonstrated no mutagenic potential, confirming drug safety profile
- Results support advancement toward larger clinical trials and commercialization
Negative
- None.
News Market Reaction – IGC
On the day this news was published, IGC gained 2.05%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
POTOMAC, MD / ACCESS Newswire / May 12, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced that it 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 ("API") 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 is an important milestone, as we prepare the drug for larger trials and eventual commercialization. The geno-tox data was presented at the annual conference on Genetic Toxicology held in Delaware, on May 8, 2025." Said Ram Mukunda CEO of IGC Pharma.
This GLP-compliant study, conducted by an independent lab in Canada, evaluated the API's mutagenic potential using the Bacterial Reverse Mutation Test (commonly known as the Ames test), as part of a broader genetic toxicology battery. The study assessed multiple bacterial strains (Salmonella typhimurium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2 trp uvrA) both in the presence (+S9) and absence (-S9) 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 µg/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 (p > 0.05), reinforcing the conclusion that the API does not induce gene mutations under the tested conditions.
To access the full poster or learn more about IGC Pharma's ongoing research, please visit the LINK.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 30 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
Forward-Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Qs filed with the SEC on August 7, 2024, November 12, 2024, and February 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.
Contact Information
Rosalyn Christian
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
FAQ
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