POTOMAC, Md.--(BUSINESS WIRE)--IGC Pharma, Inc (NYSE American: IGC) ("IGC" or the "Company"), today announced patient enrollment at Neurostudies, Inc. in Port Charlotte, Florida, for its Phase 2 clinical trial investigating IGC-AD1 as a potential treatment for Agitation in Alzheimer's disease.
IGC Pharma is currently conducting a Phase 2 trial with IGC-AD1, a partial CB1r agonist with anti-neuroinflammatory properties and an inflammasome inhibitor, to treat Agitation in dementia due to Alzheimer's disease. Neuroinflammation, neurotransmitter imbalance, loss of CB1r, and inflammasome-3 have been implicated in Agitation and aggression in patients who have dementia due to Alzheimer's. IGC-AD1 contains low doses of Tetrahydrocannabinol ("THC") as one of its two active pharmaceutical agents. THC is the principal psychoactive cannabinoid found in Cannabis. IGC-AD1 is a first-of-its-kind THC-based formulation undergoing a formal Phase 2 clinical trial in Alzheimer's disease.
Neurostudies, led by Principal Investigator Dr. Liliana Montoya and Sub-Investigator Dr. George Li, boasts over two decades of experience in clinical research. The first two patients at Neurostudies were enrolled on May 1, 2024, and May 24, 2024, signifying a critical milestone underscoring IGC Pharma's commitment to delivering shareholder value through groundbreaking advancements in Alzheimer's therapy. By expanding the trial network to include esteemed sites like Neurostudies, the Company strengthens its position in developing therapies to address unmet needs in Alzheimer's-related Agitation.
Individuals diagnosed with Alzheimer's, or their caregivers located near Port Charlotte, Florida, are encouraged to contact Neurostudies for information regarding enrolling in the trial. Contact information is available at www.neurostudiesinc.com.
Ram Mukunda, CEO of IGC Pharma, stated, "Today's announcement marks another step forward in our journey to bring IGC-AD1 to market as a therapy for Agitation in dementia due to Alzheimer's. The initiation of patient enrollment at Neurostudies underscores our strategic approach to clinical development and reaffirms our dedication to enhancing shareholder value through innovation and scientific rigor. We're confident that our innovative approach, coupled with Dr. Montoya's and Dr. Li's expertise, will pave the way for transformative advancements in Alzheimer's care."
Dr. Liliana Montoya, Principal Investigator for Neurostudies, commented, "Agitation, in particular, presents a significant challenge, both clinically and for patients and their families. Leading the team at Neurostudies in this Phase 2 clinical trial investigating IGC-AD1 is a testament to our commitment to rigorous scientific inquiry and our dedication to improving patient care. Our collaboration with IGC Pharma is an opportunity to translate scientific innovation into tangible benefits for those affected by Alzheimer's disease."
IGC Pharma has 11 additional trial sites under contract and is on target to start additional sites in the U.S. and Canada. The trial will enroll 146 patients, half receiving the active medication and the other half receiving a placebo.
About IGC Pharma, Inc.
IGC Pharma Inc. ("IGC") is focused on Alzheimer's disease, developing innovative solutions to address this devastating illness. The Company's mission is to transform the landscape of Alzheimer's treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is undergoing a Phase 2 clinical trial for Agitation in dementia associated with Alzheimer's (clinicaltrials.gov, NCT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma seeks to leverage artificial intelligence ("AI") for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's.
About Neurostudies, Inc.
Neurostudies is a premier clinical research center specializing in neurological disorders in Port Charlotte, Florida. The site is led by renowned neurologists Dr. Liliana Montoya and Dr. George Li and is dedicated to advancing clinical research to improve patient outcomes. For more information, please see www.neurostudiesinc.com.
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 Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, 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.
