IGC Pharma Announces Additional Phase 2 Interim Results Highlighting Cognitive Benefits of IGC-AD1 for Alzheimer's Treatment
25 Noviembre 2024 - 7:30AM
Business Wire
- Interim results indicate cognitive
improvement in the active treatment group compared to placebo
- No serious adverse events or deaths reported
in the trial
IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the
"Company") today announced additional interim data from its ongoing
Phase 2 clinical trial evaluating IGC-AD1. The trial focuses on
agitation in Alzheimer's as its primary outcome, with cognition
assessed as an exploratory outcome. Interim data analysis reveals
cognitive improvements in the active treatment group versus the
placebo group, marking a meaningful step toward developing a
therapy that may influence underlying disease progression.
These findings align with previously announced preclinical data,
which showed a reduction in amyloid plaque aggregation by
approximately 20% and improved spatial memory by about 50% in
Alzheimer's cell lines and mouse models, respectively.
Cognitive Improvements: A Key Marker of Disease
Progression
Cognitive decline in Alzheimer's disease reflects the
deterioration of memory, attention, language, and reasoning due to
underlying pathological changes, such as amyloid plaques and tau
tangles. Interim results from the trial demonstrated that the
active treatment group receiving IGC-AD1 twice daily for six weeks
showed an average improvement of about 8% on the Mini-Mental State
Examination ("MMSE"), a validated clinical tool for assessing
cognitive function. By contrast, the placebo group showed no
improvement over the same period.
These results and the preclinical data provide a robust
foundation for future trials focusing on cognition as the primary
endpoint and exploring IGC-AD1's disease-modifying potential.
Ram Mukunda, CEO of IGC Pharma, commented, "The cognitive
improvements observed in our interim results align with preclinical
evidence of IGC-AD1's active pharmaceutical ingredients' impact on
amyloid plaques and spatial memory. While agitation remains the
primary focus of the Phase 2 trial, these exploratory findings
strengthen our confidence in IGC-AD1's potential to address the
broader pathology of Alzheimer's disease. For patients and
caregivers, this potentially represents hope for improved care, and
for our investors, it signifies a compelling opportunity in a
growing market."
Primary Outcome: Agitation Reduction in Alzheimer's
Patients
Agitation, a debilitating symptom affecting up to 76% of
Alzheimer's patients, accelerates disease progression, increases
caregiver burden, and drives hospitalization rates. As previously
disclosed, interim results showed that IGC-AD1 significantly
reduced agitation compared to placebo, with improvements observed
as early as two weeks. Unlike the existing therapy, which often
takes about 6–10 weeks to show results and carries a black box
warning, IGC-AD1 offers rapid symptom relief with a favorable
safety profile, making it a highly differentiated potential
medication for managing agitation in Alzheimer's.
Alzheimer's disease affects 6.7 million Americans, with the
global Alzheimer's treatment market projected to exceed $50 billion
by 2025. IGC-AD1's unique profile—combining rapid onset for
agitation with potentially disease-modifying effects—positions it
as a highly differentiated therapy in this expanding field. "These
developments aim to advance IGC-AD1 toward commercialization with
more trials and regulatory approvals, potentially delivering
transformative patient care while creating significant value for
our investors," continued Ram Mukunda.
About IGC Pharma (dba IGC):
IGC Pharma is an AI-powered, clinical-stage biotechnology
company focused on developing innovative treatments for Alzheimer's
disease and transforming patient care with fast-acting, safe, and
effective solutions. Our portfolio includes the TGR family,
including TGR-63, which targets amyloid plaques, a hallmark of
Alzheimer's. The IGC-C and IGC-M platforms are advancing in
preclinical studies, focusing on metabolic disorders, tau proteins,
early plaque formation, and multiple disease hallmarks. Our lead
therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment
currently in a Phase 2 trial for agitation in dementia associated
with Alzheimer's (clinicaltrials.gov, NCT05543681). Clinical data
for IGC-AD1 demonstrated that it has the potential to transform
patient care by offering faster-acting and more effective relief
compared to traditional medications. Additionally, our AI models
are designed to predict potential biomarkers for the early
detection of Alzheimer's, optimize clinical trials, and predict
receptor affinity, among others. With 28 patent filings and a
commitment to innovation, IGC Pharma is dedicated to advancing
pharmaceutical treatments and improving the lives of those affected
by Alzheimer's and related conditions.
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 incorporates by reference
its Annual Report on Form 10-K filed with the SEC on June 24, 2024,
and on Form 10-Q filed with the SEC on August 7, 2024, 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. Contact:
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IMS Investor Relations Rosalyn Christian / Walter Frank
igc@imsinvestorrelations.com (203) 972-9200
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