IGC Pharma Expands Phase 2 Trial of IGC-AD1 to Include the University of Puerto Rico
August 02 2023 - 8:30AM
Business Wire
- First patient dosing commenced on May 19,
2023 - Trial enrollment completion and top line data expected in
early 2024
IGC Pharma, Inc (NYSE American: IGC) (“IGC” or the “Company”),
today announced the addition of an important trial site at the
University of Puerto Rico network as an expansion of the Company’s
ongoing Phase 2 clinical trial investigating lead drug asset,
IGC-AD1, as a treatment for lowering agitation in patients with
Alzheimer’s disease.
According to clinicaltrials.gov, IGC-AD1 is the only natural
THC-based investigational drug undergoing FDA trials. The therapy
relies on low doses of THC and another compound as pharmaceutical
active agents for the treatment of Alzheimer’s disease and has
shown in pre-clinical studies the potential to be effective in
ameliorating Aβ plaques and in Phase 1 the potential to reduce
neuropsychiatric symptoms such as agitation in dementia due to
Alzheimer’s.
The expansion of the Phase 2 trial into Puerto Rico aims to
increase population diversity and promote the inclusion of
underrepresented populations. The Company plans to further increase
population diversity by adding future sites in South America and
Canada. The trial will enroll 146 patients with one half, the
treated group, receiving IGC-AD1, and the other half, the control
group, receiving a placebo. The goal of the trial is to evaluate
and establish the efficacy of IGC-AD1 in helping patients with
Alzheimer’s dementia reduce neuropsychiatric symptoms (“NPS”) such
as agitation, which affects 76% of individuals with Alzheimer’s
(Mussele et al., 2015).
Dr. Vanessa Sepúlveda-Rivera, Principal Investigator for the
University of Puerto Rico trial sites commented, “Up to 12.5% of
the ageing population of Puerto Rico has Alzheimer’s Disease, which
is an increase from 10.7% reported for the continental U.S.
population. It is vital that medical research include Hispanic
populations in order to yield the most reliable data resulting in
the most effective therapies. We look forward to moving ahead with
the study and investigating this THC-based technology.”
“We are excited to announce our partnership with the University
of Puerto Rico, a remarkable institution conducting world-leading
medical research. The addition of this site with individuals living
with Alzheimer’s from the Hispanic community is a significant
milestone in our Phase 2 trial. Alzheimer’s disease, including the
resulting symptom of agitation, is complex to treat and incredibly
hard to live with,” commented Ram Mukunda, Chief Executive Officer
of IGC Pharma, Inc.
About IGC Pharma, Inc.
IGC Pharma, Inc. (dba IGC) develops advanced cannabinoid-based
formulations for treating diseases and conditions, including, but
not limited to, Alzheimer’s disease, period cramps
(“dysmenorrhea”), premenstrual syndrome (“PMS”) and chronic pain.
IGC has two investigational drug assets targeting Alzheimer’s
disease, IGC-AD1 and TGR-63, which have demonstrated in Alzheimer’s
cell lines the potential to be effective in suppressing or
ameliorating key hallmarks of Alzheimer’s disease, such as plaques
or tangles. IGC-AD1 is a low-dose tetrahydrocannabinol (“THC”)
based formulation that is currently in a 146-person Phase 2
clinical trial for agitation in dementia due to Alzheimer’s
(https://clinicaltrials.gov/ct2/show/NCT05543681). IGC also markets
a wellness brand, Holief™, that targets women experiencing
premenstrual syndrome and menstrual cramps.
Forward-looking
Statements
This press release contains forward-looking statements. These
forward-looking statements are based largely on IGC’s expectations
and are subject to several risks and uncertainties, certain of
which are beyond IGC’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; general economic
conditions that are less favorable than expected, including as a
result of the ongoing COVID-19 pandemic; the FDA’s general position
regarding cannabis- and hemp-based products; and other factors,
many of which are discussed in IGC’s U.S. Securities and Exchange
Commission (“SEC”) filings. IGC 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. In light of 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/20230802100326/en/
Investors IMS Investor Relations Walter Frank
igc@imsinvestorrelations.com (203) 972-9200
Media JVPRNY Janet Vásquez jvasquez@jvprny.com (212)
645-5498
University of Puerto Rico The Alliance (787) 759-0306
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