Clinical Trial on Alzheimer’s Patients Indicates Positive Safety and Tolerability Data for IGC’s THC-Based Investigational New Drug
December 14 2021 - 9:25AM
Business Wire
(NYSE American: IGC), India Globalization Capital, Inc. (“IGC”
or the “Company”) today announced positive primary endpoint data
for its Phase 1 clinical trial for IGC-AD1, which is a proprietary
cannabinoid-based investigational new drug candidate for patients
who have Alzheimer’s disease.
During the Phase 1 trial, minimal adverse events were reported,
and IGC-AD1 was tolerated with no safety concerns identified by an
independent Data Safety Monitoring Board. The Company has submitted
the clinical trial data in its Clinical/Statistical Report (“CSR”)
filed with the U.S. Food and Drug Administration (FDA) on December
1, 2021. In addition, as previously disclosed, data from the
secondary and exploratory endpoints are also available on Form 8-K
filed with the SEC on December 2, 2021.
In the short term, our strategy with IGC-AD1 is to demonstrate
safety and tolerability, then, subject to FDA approval, to test and
show efficacy in a large and diverse trial focused on symptoms
associated with dementia in Alzheimer’s.
If our clinical trials satisfactorily demonstrate safety,
tolerability, and efficacy, the Company’s goal is to apply to the
FDA for approval of IGC-AD1 as a new drug.
The primary endpoint of our Phase 1 clinical trial was to test
and demonstrate safety and tolerability. The trial was conducted as
a multiple ascending dose (MAD) study. There were three Cohorts,
with 12 patients in each cohort. Patients in Cohort 1, Cohort 2,
and Cohort 3 received one, two, and three doses of IGC-AD1 per day,
respectively, for 14 days.
The participants were a frail geriatric population with multiple
comorbidities and mild to moderate Alzheimer’s disease. The average
age was 80.9 years, and the average weight was 141.2 pounds. In
addition, 66.7% of participants were women, and 33.3% were men.
Safety and Tolerability (S&T) was assessed by asking
participants to record Adverse Events (AEs). Participant recorded
AEs included drowsiness (somnolence), falls, dizziness,
weakness/lack of energy (asthenia), suicidal thoughts,
hypertension, psychiatric symptoms, and paradoxical nausea. Each
participant had a caregiver that assisted with the daily reporting.
Using an FDA-defined protocol, the AEs were graded as mild,
moderate, severe, life-threatening, and serious.
Across all three Cohorts, there were no serious or
life-threatening AEs. There were no deaths, and no participant
dropped out of the study due to the medication. Mild dizziness was
reported by one patient in Cohort 1 that was deemed to be related
to IGC-AD1. Apart from the mild dizziness, which self-resolved with
no intervention, all other AEs across all three Cohorts were deemed
unrelated to IGC-AD1 or the placebo.
The Company is encouraged by the data collected that indicates
that even at the higher dosing levels tested in the Phase 1 trial,
serious or life-threatening AEs did not result from the
administration of ICG-AD1. Subject to FDA approval, the Company
looks forward to continuing clinical trial testing of IGC-AD1 for
safety, tolerability, and efficacy with the hope for a better life
for people living with Alzheimer’s.
About IGC:
India Globalization Capital, Inc. (IGC), based in Maryland,
engages in developing cannabinoid-based therapies for healthcare
applications. The Company’s Life Science business recently
completed a Phase 1 clinical trial on Alzheimer’s patients using a
cannabinoid-based investigational new drug. The Company also
operates an India-based infrastructure business. 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/20211214005476/en/
Claudia Grimaldi info@igcinc.us Phone: 301-983-0998
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