Phase 1 Clinical Trial Data Indicate IGC’s THC-based Investigational New Drug May Reduce Symptoms of Dementia in Alzheimer’s Patients
December 02 2021 - 9:32AM
Business Wire
(NYSE American: IGC), India Globalization Capital, Inc. (IGC) is
excited to present preliminary positive secondary end point
findings from its Phase 1 clinical trial for IGC-AD1. The
investigational new drug, IGC-AD1, is IGC’s proprietary
Tetrahydrocannabinol (THC)-based candidate designed to treat
certain symptoms of Alzheimer’s disease. The results of the
clinical trial have been submitted in the Clinical/Statistical
Report (“CSR”) filed with the FDA, and relevant data is also
available on Form 8-K filed with the SEC on December 2, 2021.
Alzheimer’s disease impacts about 50 million people worldwide
and about 5.5 million individuals in the U.S. Over 70% of these
patients face one or more debilitating symptoms, including anxiety,
depression, and agitation (Mendez, 2021). Agitation in dementia
patients can include excessive physical movement and verbal
activity, restlessness, pacing, belligerence, aggression,
screaming, crying, and wandering. Currently, there is no
FDA-approved medication to alleviate symptoms of dementia, such as
agitation, due to Alzheimer’s disease.
To the best of our knowledge, this is the first human clinical
trial combining low doses of THC with another molecule to treat
symptoms of dementia in Alzheimer’s patients. THC is a naturally
occurring cannabinoid produced by the cannabis plant. It is known
for being a psychoactive substance that can impact mental processes
in a positive or negative way depending on dosage. THC is biphasic,
meaning that low and high doses of the substance may affect mental
and physiological processes in substantially different ways. Our
trial is based on low or microdosing, which is hypothesized to
potentially have a promising effect on Alzheimer’s patients.
As previously disclosed the recently closed trial was approved
to proceed by the U.S. Food and Drug Administration (FDA) on July
30, 2020. The trial included three cohorts, with 12 patients in
each cohort. Patients in Cohort-1, Cohort-2 and Cohort-3 received
the medication once, twice, and thrice per day, respectively, for
14 days. To evaluate one of the secondary end points for the study,
neuropsychiatric symptoms of patients, across all cohorts, were
assessed on day zero of each cohort to establish a baseline, as
well as on day 10, and day 15 of each cohort.
Based solely on the data collected over the course of the Phase
1 trial, we saw evidence of clinical improvements in anxiety,
depression, and agitation. On the anxiety and depression scales, we
documented a decrease of approximately 50% to 60% in patients who
received the drug. For agitation, we documented a decrease of
approximately 35% to 60% in patients who received the drug. The
degree of the decrease varied by cohort. Based on the preliminary
data obtained to date, IGC estimates that the most effective dosage
of the drug may be once or twice per day, depending on the symptom.
As previously disclosed, we have received an initial patent, and
filed additional patents to protect our intellectual property.
As this was a Phase 1 trial, data collected related to
neuropathic symptoms are preliminary in nature and are not a
guarantee of future positive results. Nevertheless, IGC is
encouraged by these initial promising and exciting results, as the
potential to improve the quality of life of Alzheimer’s patients
and their caregivers could be significant if similar results are
repeated in future trials with larger patient pools. We are in the
process of using the results from this Phase 1 study to design and
subsequently pursue, based on FDA approval, a placebo-controlled,
multi-site trial with a significantly expanded patient population
to further test the efficacy of IGC-AD1 on agitation, anxiety, and
depression in Alzheimer’s patients. The details of a clinical trial
process in general are documented in IGC’s annual report.
IGC-AD1 is an investigational new drug that has not been
approved as a medication by any regulatory body in any country.
Although the Phase 1 trial has been completed, and certain data has
been collected, IGC-AD1’s safety and efficacy need to be further
established through trials on larger and more diverse groups of
Alzheimer’s patients.
About IGC:
India Globalization Capital, Inc. (IGC) engages in the
development of cannabinoid-based therapies for healthcare
applications. The company currently operates two lines of business:
life sciences and infrastructure. The life sciences business
recently completed the first safety and tolerability clinical trial
to treat symptoms of Alzheimer’s patients using a THC-based
investigational new drug. In addition, we produce and sell
over-the-counter hemp-based women’s health products, including for
post menstrual symptoms (PMS) and dysmenorrhea. The second line of
business is an infrastructure business based in India. IGC
headquartered in Potomac, MD.
www.igcinc.us, www.igcpharma.com.
Forward-Looking Statements:
This press release contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934.
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 investigational new drug or formulation
described in this release, or failure to obtain FDA approval for
the investigational new drug or additional clinical trials; testing
results from human clinical trials that may not be favorable or as
anticipated or consistent with the results obtained from Phase 1
trials; 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
SEC filings. IGC incorporates by reference the human trial
disclosures and Risk Factors identified in its Annual Reports on
Form 10-K filed with the SEC on June 14, 2021, and Quarterly Report
on Form 10-Q, filed with the SEC on August 11, 2021, and October
29, 2021 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/20211202005635/en/
Claudia Grimaldi info@igcinc.us Phone: 301-983-0998
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