IGC Pharma Announces Patient Enrollment at Toronto's Baycrest in Phase 2 Trial Investigating IGC-AD1

Rhea-AI Summary

IGC Pharma (NYSE American:IGC) has announced the enrollment of patients at Baycrest Academy for Research and Education in Toronto, Canada, for its ongoing Phase 2 trial of IGC-AD1, a treatment for agitation in Alzheimer's dementia. IGC-AD1 is a partial CB1 receptor agonist with anti-neuroinflammatory properties, targeting key pathways involved in Alzheimer's disease pathology. The trial expansion to Canada follows approval from Health Canada.

Dr. Howard Chertkow, Chair of Cognitive Neurology and Innovation at Baycrest, emphasized the importance of this study in addressing behavioral symptoms of Alzheimer's. The trial will enroll 164 patients, with half receiving IGC-AD1 and half receiving a placebo. IGC Pharma currently has 12 U.S. trial sites under contract and plans to add more in Canada to increase population diversity.

Positive

• Expansion of Phase 2 trial to Canada, increasing study scope and diversity
• Enrollment of patients at prestigious Baycrest Academy in Toronto
• IGC-AD1 targets multiple pathways involved in Alzheimer's disease pathology
• 12 U.S. trial sites already under contract
• Plans to enroll additional sites in Canada

Negative

• None.

Insights

Medical Research Analyst

The expansion of IGC Pharma's Phase 2 trial for IGC-AD1 to Canada, specifically at Baycrest in Toronto, is a significant development in their Alzheimer's agitation treatment research. This move broadens the trial's geographical scope and patient diversity, which is important for robust clinical data. The involvement of Baycrest, a renowned institution in geriatric care and brain health, adds credibility to the study.

Key points to consider:

• The trial targets agitation in Alzheimer's, affecting 40-80% of patients, a substantial market.
• IGC-AD1's mechanism as a partial CB1 receptor agonist with anti-neuroinflammatory properties addresses multiple pathways in Alzheimer's pathology.
• The study aims to enroll 164 patients, with half receiving IGC-AD1 and half placebo, providing a robust sample size for efficacy assessment.
• Expansion to 12 U.S. sites and additional Canadian sites enhances patient recruitment and data diversity.

While this news shows progress in IGC's clinical program, investors should note that Phase 2 results are still pending and success is not guaranteed. The outcome of this trial will be important in determining IGC-AD1's potential and IGC Pharma's future in the competitive Alzheimer's treatment market.

- Company Expands Phase 2 trial to Canada -

POTOMAC, MD / ACCESSWIRE / October 17, 2024 / IGC Pharma, Inc (NYSE American:IGC) ("IGC" or the "Company"), today announced enrollment of patients at the Baycrest Academy for Research and Education in Toronto, Ontario, Canada, as part of the Company's ongoing Phase 2 trial investigating IGC-AD1 as a treatment for agitation in Alzheimer's dementia.

Agitation affects between 40-80% of Alzheimer's patients and is a major driver of long-term hospitalization, increased mortality, and higher use of medication.

IGC-AD1 is a partial CB1 receptor agonist with anti-neuroinflammatory properties and acts as an inflammasome inhibitor, addressing key pathways involved in the neuroinflammation, oxidative stress, and neurotransmitter imbalances that are implicated with agitation in Alzheimer's disease pathology.

Baycrest is a global leader in geriatric residential living, healthcare, research, innovation and education, with a special focus on brain health and aging. The research site is in the North York district of Toronto, Ontario, Canada.

Dr. Howard Chertkow, Chair of Cognitive Neurology and Innovation at Baycrest commented, "The initiation of patient enrollment at Baycrest for the Phase 2 trial of IGC-AD1 is an important step in our efforts to combat the challenging behavioral symptoms of agitation in Alzheimer's disease. This study aims to explore the potential of IGC-AD1 in providing relief to patients suffering from these distressing symptoms. We encourage the caregivers of patients with Alzheimer's and symptoms such as pacing, uncooperativeness, resistive to help from others, repetitive movements, hording, negativism, constant complaining, physical or verbal aggression, among others, to contact our center and inquire about enrolling the patient in the trial. The trial requires the caregiver to spend time with the patient daily, maintain a logbook, and accompany the patient to our center four times over a six-week period."

Ram Mukunda, CEO of IGC Pharma stated, "Having obtained permission to conduct trials from Health Canada, we are excited to expand our Phase 2 trial to a prestigious site such as Baycrest under the direction of Dr. Chertkow, a distinguished cognitive neurologist and exceptionally prolific researcher of Alzheimer's dementia. Their renowned expertise in brain health and aging are invaluable for advancing our clinical trial."

IGC Pharma have 12 U.S. trial sites under contract and is on target to enroll additional sites in Canada to increase population diversity. The trial will enroll 164 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo.

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.

About Baycrest:
Baycrest is an internationally recognized leader providing exceptional seniors health and residential care with a strategic focus on brain health and aging. Baycrest programs are devoted to holistic aging health, active dementia prevention, early detection of cognitive decline, and treatment and care for physical and cognitive frailty, dementia and other brain disorders. Baycrest leads Canada's largest federally funded dementia research program (CCNA), co-chaired the inaugural Government of Canada's Dementia Advisory Board tasked with developing the nation's dementia strategy, and provides training in "next generation" older adult care across the world. We strive to defeat dementia and create a world where every older adult enjoys a life of purpose, inspiration and fulfilment. Contact information is available at Baycrest.

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 Information
Rosalyn Christian / Walter Frank
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on accesswire.com

FAQ

What is the purpose of IGC Pharma's Phase 2 trial for IGC-AD1?

The Phase 2 trial is investigating IGC-AD1 as a treatment for agitation in Alzheimer's dementia, which affects 40-80% of Alzheimer's patients and is a major driver of long-term hospitalization and increased mortality.

How many patients will be enrolled in IGC Pharma's Phase 2 trial for IGC-AD1?

The trial will enroll 164 patients, with half receiving IGC-AD1 and half receiving a placebo.

Where is IGC Pharma (IGC) conducting its Phase 2 trial for IGC-AD1?

IGC Pharma is conducting the trial at 12 U.S. sites and has expanded to Canada, with patient enrollment at Baycrest Academy in Toronto. The company plans to add more sites in Canada to increase population diversity.

What are the mechanisms of action for IGC Pharma's (IGC) IGC-AD1?

IGC-AD1 is a partial CB1 receptor agonist with anti-neuroinflammatory properties and acts as an inflammasome inhibitor, addressing key pathways involved in neuroinflammation, oxidative stress, and neurotransmitter imbalances in Alzheimer's disease.