IGC Pharma Announces Patient Enrollment at Neurostudies in Phase 2 Trial Investigating IGC-AD1
May 28 2024 - 9:00AM
Business Wire
-- Advancing IGC-AD1 Toward Commercialization
as a Treatment for Agitation in Alzheimer's --
IGC Pharma, Inc (NYSE American: IGC) ("IGC" or the "Company"),
today announced patient enrollment at Neurostudies, Inc. in Port
Charlotte, Florida, for its Phase 2 clinical trial investigating
IGC-AD1 as a potential treatment for Agitation in Alzheimer's
disease.
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 in dementia due to
Alzheimer's disease. Neuroinflammation, neurotransmitter imbalance,
loss of CB1r, and inflammasome-3 have been implicated in Agitation
and aggression in patients who have dementia due to Alzheimer's.
IGC-AD1 contains low doses of Tetrahydrocannabinol ("THC") as one
of its two active pharmaceutical agents. THC is 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.
Neurostudies, led by Principal Investigator Dr. Liliana Montoya
and Sub-Investigator Dr. George Li, boasts over two decades of
experience in clinical research. The first two patients at
Neurostudies were enrolled on May 1, 2024, and May 24, 2024,
signifying a critical milestone underscoring IGC Pharma's
commitment to delivering shareholder value through groundbreaking
advancements in Alzheimer's therapy. By expanding the trial network
to include esteemed sites like Neurostudies, the Company
strengthens its position in developing therapies to address unmet
needs in Alzheimer's-related Agitation.
Individuals diagnosed with Alzheimer's, or their caregivers
located near Port Charlotte, Florida, are encouraged to contact
Neurostudies for information regarding enrolling in the trial.
Contact information is available at www.neurostudiesinc.com.
Ram Mukunda, CEO of IGC Pharma, stated, "Today's announcement
marks another step forward in our journey to bring IGC-AD1 to
market as a therapy for Agitation in dementia due to Alzheimer's.
The initiation of patient enrollment at Neurostudies underscores
our strategic approach to clinical development and reaffirms our
dedication to enhancing shareholder value through innovation and
scientific rigor. We're confident that our innovative approach,
coupled with Dr. Montoya's and Dr. Li's expertise, will pave the
way for transformative advancements in Alzheimer's care."
Dr. Liliana Montoya, Principal Investigator for Neurostudies,
commented, "Agitation, in particular, presents a significant
challenge, both clinically and for patients and their families.
Leading the team at Neurostudies in this Phase 2 clinical trial
investigating IGC-AD1 is a testament to our commitment to rigorous
scientific inquiry and our dedication to improving patient care.
Our collaboration with IGC Pharma is an opportunity to translate
scientific innovation into tangible benefits for those affected by
Alzheimer's disease."
IGC Pharma has 11 additional trial sites under contract and is
on target to start additional sites in the U.S. and Canada. The
trial will enroll 146 patients, half receiving the active
medication and the other half receiving a placebo.
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 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.
About Neurostudies, Inc.
Neurostudies is a premier clinical research center specializing
in neurological disorders in Port Charlotte, Florida. The site is
led by renowned neurologists Dr. Liliana Montoya and Dr. George Li
and is dedicated to advancing clinical research to improve patient
outcomes. For more information, please see
www.neurostudiesinc.com.
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/20240528903366/en/
Investors IMS Investor Relations Walter Frank
igc@imsinvestorrelations.com (203) 972-9200
Media JVPRNY Janet Vasquez jvasquez@jvprny.com (212)
645-5498
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