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IGC Pharma Publishes Study in European Society of Medicine Investigating the Impact of CYP2C9 Genetic Polymorphism on Pharmacokinetics of Delta 9 Tetrahydrocannabinol

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IGC Pharma announced a new study published in the European Society of Medicine Journal examining the impact of CYP2C9 genetic polymorphisms on the pharmacokinetics of delta-9-tetrahydrocannabinol (THC) in Alzheimer's patients. The study, conducted with Puerto Rican participants, revealed significant variations in THC metabolism among different genetic profiles, underscoring the importance of personalized medicine.

IGC is currently in Phase 2 trials of IGC-AD1, a THC-based drug candidate aimed at treating agitation in Alzheimer's patients. The research aligns with IGC's commitment to include underrepresented populations and develop innovative treatments. CEO Ram Mukunda and lead scientist Dr. Jagadeesh S. Rao highlighted the study's importance for personalized dosing strategies in Alzheimer's care.

Positive
  • Publication in a prestigious journal boosts IGC Pharma's credibility.
  • Study reveals significant genetic variations, emphasizing the need for personalized medicine.
  • Phase 2 trial of IGC-AD1 is underway, showing progress in drug development.
  • Focus on underrepresented populations enhances inclusivity in clinical research.
  • Commitment to innovative Alzheimer's treatments could attract investor interest.
Negative
  • No immediate financial gains or revenue increases reported.
  • Research findings may require more investment for personalized dosing strategies.
  • Potential delays in drug approval processes due to the need for tailored treatments.

Insights

IGC Pharma's recent study on the impact of CYP2C9 genetic polymorphisms on the pharmacokinetics of delta-9-tetrahydrocannabinol (THC) presents noteworthy insights for Alzheimer's disease (AD) treatment, particularly given the genetic variability in drug metabolism. The research emphasizes the importance of personalized medicine, as it showcases significant differences in THC and OH-THC half-life among various CYP2C9 phenotypes. This understanding could lead to more effective dosing strategies and improved patient outcomes.

In terms of broader implications, examining specific genetic profiles can help minimize adverse effects and boost therapeutic efficacy. This approach aligns with current trends in precision medicine, aiming for more targeted treatments. It's crucial, however, to note that this is a Phase 1 trial, indicating that while the findings are promising, they are preliminary. Additionally, being focused on Puerto Rican AD patients, the study addresses the need for inclusivity in clinical research, potentially improving treatment efficacy for underrepresented populations.

Given the complexities of neurodegenerative diseases and the varied responses to treatments, this study's outcomes could significantly impact the future of AD therapies, promising more tailored approaches based on genetic differences.

From a financial perspective, IGC Pharma's publication in the European Society of Medicine Journal is a promising development. The focus on CYP2C9 polymorphisms and their impact on THC metabolism in Alzheimer's patients suggests potential for innovation in a highly competitive and lucrative market. Alzheimer's disease treatments represent a substantial market, with potential revenues in the billions. The company's move toward personalized medicine could lead to a competitive advantage, potentially attracting investors and partnerships.

Nevertheless, investors should be cautious due to the early-stage nature of these trials. Phase 1 results are encouraging, but it remains necessary to await further phases to confirm efficacy and safety. The market tends to react positively to novel scientific findings, but sustained interest hinges on continued progress through clinical trials and eventual regulatory approvals.

Moreover, the inclusion of underrepresented populations in their studies can enhance the company's reputation and accessibility to a broader market, potentially leading to higher adoption rates and improved sales in the long run.

-- Study Deepens Understanding of Treatments for Alzheimer’s Patients, Enabling More Effective Treatments --

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”), today announced the publication of a significant research article in the European Society of Medicine Journal. The study investigates the effects of CYP2C9 polymorphisms on the pharmacokinetics (“PK”) of delta-9-tetrahydrocannabinol (“THC”) and its active metabolite in Alzheimer’s disease (“AD”) patients.

The publication is titled “A study on CYP2C9 polymorphism in Puerto Rican Alzheimer's Patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol” and is available at https://esmed.org/MRA/mra/article/view/5380.

The article highlights the importance of understanding genetic variations in CYP2C9, an enzyme crucial for drug metabolism, and its impact on the efficacy and safety of treatments involving THC. IGC Pharma’s leading drug candidate IGC-AD1 was tested in a Phase 1 multiple ascending dose (“MAD”) trial with a Puerto Rican population. The study examined the effect of CYP2C9 polymorphisms on THC metabolism in AD patients. Key findings revealed significant variations in THC and OH-THC half-life among different CYP2C9 phenotypes, suggesting the need for personalized dosing strategies in AD patients.

The publication of the article aligns with IGC Pharma’s commitment to the inclusion of underrepresented populations in clinical research developing innovative Alzheimer's therapies. Puerto Rico, with an elevated AD rate of 12% compared to 10.7% in the continental US, was chosen to ensure comprehensive data collection and improve the accessibility of effective therapies.

Ram Mukunda, CEO of IGC Pharma, commented, “We are very pleased to announce the publication in the prestigious European Society of Medicine journal. This publication is a testament to our dedication to pioneering research in Alzheimer’s disease. Understanding the genetic factors influencing drug metabolism is critical for developing safe and effective treatments. We are proud to contribute to the scientific community with this important study, reinforcing our commitment to enhancing patient care and delivering shareholder value through scientific innovation.”

Dr. Jagadeesh S. Rao, the lead scientist of the study, stated, “Our findings emphasize the critical need for personalized medicine in treating Alzheimer’s disease. The significant variability in THC metabolism due to CYP2C9 polymorphisms highlights the importance of considering genetic profiles when dosing. This research paves the way for more tailored therapeutic approaches, potentially improving outcomes for AD patients.”

IGC Pharma is currently conducting a Phase 2 trial with IGC-AD1, a partial CB1r agonist with anti-neuroinflammatory properties and an inflammasome inhibitor, to treat agitation from symptoms of dementia caused by Alzheimer’s. Neuroinflammation, neurotransmitter imbalance, loss of CB1r, and inflammasome-3 have been implicated as causes of agitation and aggression in patients suffering from Alzheimer’s disease. IGC-AD1 contains THC as one of its two active pharmaceutical agents, the principal psychoactive cannabinoid found in Cannabis. IGC-AD1 is a first-of-its-kind THC-based-formulation undergoing a formal Phase 2 clinical trial in Alzheimer’s disease.

About IGC Pharma, Inc.

IGC Pharma Inc. (“IGC”) is focused on Alzheimer’s disease, developing innovative solutions to address this devastating illness. The Company’s mission is to transform the landscape of Alzheimer’s treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer’s disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2 clinical trial for agitation in dementia associated with Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 disrupts the progression of Alzheimer’s by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer’s. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer’s therapy. In addition to its drug development pipeline, IGC Pharma seeks to leverage artificial intelligence (“AI”) for Alzheimer’s research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer’s.

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 Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, 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.

Investors

IMS Investor Relations

Walter Frank/Rosalyn Christian

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What is the significance of the IGC Pharma study published in the European Society of Medicine Journal?

The study highlights the impact of CYP2C9 genetic polymorphisms on THC metabolism in Alzheimer's patients, emphasizing the need for personalized medicine.

What were the key findings of IGC Pharma's study on THC metabolism?

The study found significant variations in THC and OH-THC half-life among different CYP2C9 phenotypes, suggesting the need for personalized dosing strategies in Alzheimer's patients.

Why did IGC Pharma conduct their study with a Puerto Rican population?

Puerto Rico was chosen due to its higher Alzheimer's disease rate and to ensure comprehensive data collection, improving the accessibility of effective therapies.

What is IGC-AD1?

IGC-AD1 is a THC-based drug candidate undergoing Phase 2 clinical trials to treat agitation in Alzheimer's patients.

How does the study published by IGC Pharma impact Alzheimer's treatment?

The study emphasizes the importance of personalized medicine, potentially leading to more effective and safer treatments for Alzheimer's patients based on genetic profiles.

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