Phase 1 Clinical Trial Provides Valuable Insights on Safe and Effective Dosing of IGC-AD1 for Alzheimer’s Patients
December 08 2021 - 5:43PM
Business Wire
(NYSE American: IGC), India Globalization Capital, Inc. (IGC)
today announces preliminary results for its exploratory endpoints
from its Phase 1 IGC-AD1 clinical trial. IGC-AD1 is a proprietary
cannabis-based investigational new drug candidate for patients
suffering from Alzheimer’s disease. The Phase 1 clinical trial
provided valuable insights on Pharmacokinetics (PK) and genotyping
that will be essential in determining optimal dosing moving into
subsequent trials, subject to U.S. Food and Drug Administration
(FDA) approval.
The clinical trial results were submitted in the
Clinical/Statistical Report (“CSR”) filed with the FDA on December
1, 2021. In addition, as previously disclosed, data from the
secondary endpoints, neuropsychiatric symptoms in Alzheimer’s
patients, and other relevant data are available on Form 8-K filed
with the SEC on December 2, 2021.
Alzheimer’s disease impacts about 50 million people worldwide,
and approximately 66% are women (alz.org). Unfortunately, there is
no cure for Alzheimer’s and no FDA-approved pharmaceuticals to
treat many of the symptoms, including agitation, in
Alzheimer’s.
Pharmacokinetics
Pharmacokinetics studies how long it takes for the body to
absorb, process, metabolize, and eliminate a drug after being
administered. Understanding how long it takes a drug to produce the
intended effects and when those effects will diminish can help
determine the appropriate and safe frequency of dosing.
Tetrahydrocannabinol (THC), the principal psychoactive component
of cannabis, is metabolized by the CYP4502C9 enzyme. This enzyme is
also responsible for metabolizing and eliminating many other
families of drugs, including S-warfarin, tolbutamide, phenytoin,
losartan, diclofenac, and celecoxib. The CYP4502C9 enzyme converts
THC to its active metabolite OH-THC.
The trial measured Tmax, the length of time it takes for the
substance to reach its maximum concentration in the body, and T1/2,
which is the length of time it takes for the concentration to
decline to half the Tmax value. These two metrics provide guidance
on when the maximum effects of the drug will be felt and when the
impact of the drug will start to decline significantly. We measured
Tmax and T1/2 for both THC and the metabolized substance
OH-THC.
- The mean Tmax was 2.15 hours (range 1.0-3.5) for THC and 1.9
hours (range 1.0-4.0) for OH-THC
- The mean T1/2 was 3.60 hours (range 0.7-12.87) for THC and 3.30
hours (range 1.05-5.7) for OH-THC
These results indicate that dosing two or three times per day
may be safe for patients, as the first and potentially second dose
would be eliminated from the body before subsequent doses are
given.
Genotyping
The CYP2C9 gene encodes the cytochrome CYP2CP enzyme. This gene
is highly polymorphic, which means not everyone makes the gene in
the same way. Variations in the gene can impact the level of enzyme
activity and how quickly the bodily metabolizes substances,
including THC. These variations are stratified into groups of
metabolizers - poor (PM), intermediate (IM), normal (NM), and
ultra-rapid (UM) (Gaedigk A, et al., 2008; Caudle K E, et al.,
2017)
We used a blood test to determine that 62% of the study
population (N=13) were classified as IM and 38% NM. 100% of study
participants were of Hispanic ethnicity. The IM / NM split was
consistent with the known distribution of the overall Hispanic
population but may not be representative of other populations.
The Tmax values were close for IM and NM participants. However,
the T1/2 of THC and OH-THC did vary. This indicates, subject to
more trials, that optimal dosing frequency could vary based on a
person’s polymorphism of the CYP2CP gene.
- THC: Tmax was 2.38 hours for the NM group and 2.00 hours for
the IM group
- OH-THC: Tmax 1.75 hours for the NM and 2.00 hours for the IM
group
- THC: T1/2 was 1.73 hours for the NM group and 5.09 hours for
the IM group
- OH-THC: T1/2 was 2.98 for the NM group and 3.51 hours for the
IM group
We plan to use the results from this study to inform the design
of Phase 2 and Phase 3 clinical trials, subject to FDA approval.
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, tolerability, 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 a Phase 1 clinical trial on Alzheimer’s patients
using a THC-based investigational new drug. The second line of
business is an infrastructure business based in India. IGC is
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/20211208006098/en/
Claudia Grimaldi info@igcinc.us Phone: 301-983-0998
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