IGC Pharma Publishes Study in European Society of Medicine Investigating the Impact of CYP2C9 Genetic Polymorphism on Pharmacokinetics of Delta 9 Tetrahydrocannabinol
June 10 2024 - 9:00AM
Business Wire
-- Study Deepens Understanding of Treatments
for Alzheimer’s Patients, Enabling More Effective Treatments --
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240610337877/en/
Investors IMS Investor Relations Walter Frank/Rosalyn
Christian igc@imsinvestorrelations.com (203) 972-9200
Media JVPRNY Janet Vasquez jvasquez@jvprny.com (212)
645-5498
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