IGC Pharma Presents Genetic Toxicology Safety Data on API in IGC-AD1, at the 2025 Genetic Toxicology Association Meeting
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.
IGC Pharma (NYSE American: IGC) ha presentato dati chiave sulla sicurezza genetica tossicologica di uno degli ingredienti farmaceutici attivi (API) presenti in IGC-AD1, il suo farmaco sperimentale per l'Alzheimer, durante il Congresso Annuale 2025 della Genetic Toxicology Association. Lo studio, condotto da un laboratorio canadese indipendente, ha valutato il potenziale mutageno della melatonina utilizzando il Test di Mutazione Inversa Batterica (test di Ames).
Lo studio conforme alle norme GLP ha testato diverse ceppi batterici a concentrazioni variabili da 1,6 a 5000 µg/piastra. I risultati non hanno mostrato alcuna evidenza di mutagenicità a nessun livello di dose, con valori di Fold Response sempre al di sotto della soglia di attività mutagena. Questo importante traguardo di sicurezza supporta lo sviluppo di IGC-AD1 mentre l'azienda si prepara a studi clinici più ampi e a una possibile commercializzazione.
IGC Pharma (NYSE American: IGC) presentó datos clave de seguridad genética toxicológica para uno de los ingredientes farmacéuticos activos (API) en IGC-AD1, su medicamento experimental para la enfermedad de Alzheimer, en la Reunión Anual 2025 de la Genetic Toxicology Association. El estudio, realizado por un laboratorio independiente canadiense, evaluó el potencial mutagénico de la melatonina mediante la Prueba de Mutación Inversa Bacteriana (test de Ames).
El estudio, conforme a las normas GLP, probó varias cepas bacterianas a concentraciones de 1.6 a 5000 µg/placa. Los resultados no mostraron ninguna evidencia de mutagenicidad en ningún nivel de dosis, con valores de Fold Response por debajo del umbral de actividad mutagénica. Este hito de seguridad respalda el desarrollo de IGC-AD1 mientras la compañía se prepara para ensayos más amplios y una posible comercialización.
IGC Pharma (NYSE American: IGC)는 2025년 유전독성학회 연례회의에서 알츠하이머병 치료제 후보인 IGC-AD1의 활성 약물 성분(API) 중 하나에 대한 주요 유전 독성 안전성 데이터를 발표했습니다. 캐나다 독립 연구소에서 수행한 이 연구는 박테리아 역돌연변이 검사(Ames 검사)를 사용하여 멜라토닌의 돌연변이 유발 가능성을 평가했습니다.
GLP 기준에 따라 진행된 이 연구는 1.6에서 5000 µg/플레이트 농도 범위에서 여러 박테리아 균주를 시험했습니다. 결과는 모든 용량 수준에서 돌연변이 유발 증거가 없음을 보여주었으며, Fold Response 값은 돌연변이 활성 임계값 이하로 유지되었습니다. 이 안전성 성과는 IGC-AD1의 개발을 뒷받침하며, 회사가 더 큰 임상시험과 잠재적 상용화를 준비하는 데 중요한 역할을 합니다.
IGC Pharma (NYSE American : IGC) a présenté des données clés sur la sécurité génétique toxicologique d'un des principes actifs (API) de l'IGC-AD1, son médicament expérimental contre la maladie d'Alzheimer, lors de la réunion annuelle 2025 de la Genetic Toxicology Association. L'étude, réalisée par un laboratoire indépendant canadien, a évalué le potentiel mutagène de la mélatonine à l'aide du test de mutation inverse bactérienne (test d'Ames).
Cette étude conforme aux bonnes pratiques de laboratoire (BPL) a testé plusieurs souches bactériennes à des concentrations allant de 1,6 à 5000 µg/plateau. Les résultats n'ont montré aucune preuve de mutagénicité à aucun niveau de dose, les valeurs de Fold Response restant en dessous du seuil d'activité mutagène. Cette étape importante en matière de sécurité soutient le développement de l'IGC-AD1 alors que la société se prépare à des essais plus vastes et à une éventuelle commercialisation.
IGC Pharma (NYSE American: IGC) präsentierte auf der Jahrestagung 2025 der Genetic Toxicology Association wichtige genetisch-toxikologische Sicherheitsdaten für einen der Wirkstoffe (APIs) in IGC-AD1, dem experimentellen Alzheimer-Medikament des Unternehmens. Die Studie, durchgeführt von einem unabhängigen kanadischen Labor, bewertete das mutagene Potenzial von Melatonin mittels des Bakterien-Reversionstests (Ames-Test).
Die GLP-konforme Studie testete mehrere Bakterienstämme in Konzentrationen von 1,6 bis 5000 µg/Platte. Die Ergebnisse zeigten keine Hinweise auf Mutagenität bei keiner Dosierung, wobei die Fold-Response-Werte unter der Schwelle für mutagene Aktivität blieben. Dieser Sicherheitsmeilenstein unterstützt die Weiterentwicklung von IGC-AD1, während das Unternehmen sich auf größere Studien und eine potenzielle Kommerzialisierung vorbereitet.
- 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
- None.
Insights
IGC Pharma's genetic toxicology data for IGC-AD1 shows melatonin passed FDA-required safety testing, a key regulatory milestone for their Alzheimer's drug.
The genetic toxicology data presented by IGC Pharma represents a significant regulatory milestone in their development pathway for IGC-AD1. The company has successfully completed the Bacterial Reverse Mutation Assay (Ames test) for melatonin, one of the two active pharmaceutical ingredients in their Alzheimer's disease candidate.
This testing is part of the FDA's required battery of safety assessments that must be completed before advancing to larger clinical trials. The data specifically demonstrates that melatonin does not induce gene mutations across multiple bacterial strains at concentrations ranging from 1.6 to 5000 µg/plate, both with and without metabolic activation.
The study's compliance with Good Laboratory Practice (GLP) standards and adherence to OECD Guideline 471 and ICH S2(R1) recommendations adds regulatory credibility to these findings. The fact that the testing was conducted by an independent laboratory in Canada further strengthens the objectivity of the results.
While this represents progress in the safety assessment pathway, investors should note this addresses only one component of the comprehensive toxicology package required by regulators. The company will still need to complete additional genetic toxicology studies, along with other non-clinical safety assessments, before receiving clearance for expanded clinical trials. The press release doesn't mention the testing status of the second API in the combination product, which will also require similar validation.
This milestone suggests the company is methodically advancing through the regulatory requirements for their Alzheimer's candidate, though several additional steps remain before potential commercialization.
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
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