IGC Pharma announces patient enrollment at Neurostudies in Phase 2 trial investigating IGC-AD1

Advancing IGC-AD1 Toward Commercialization as a Treatment for Agitation in Alzheimer's

IGC Pharma 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.