IGC Pharma Expands Phase 2 CALMA Clinical Trial to University of South Florida's Department of Psychiatry and Behavioral Neurosciences
Rhea-AI Summary
IGC Pharma (NYSE American:IGC) announced expansion of its Phase 2 CALMA trial of investigational IGC-AD1 for agitation in Alzheimer's disease with a new clinical site at the University of South Florida Department of Psychiatry and Behavioral Neurosciences effective October 14, 2025.
Enrollment at the USF site has begun with four participants already enrolled. CALMA is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of IGC-AD1; the company says the USF site will help accelerate recruitment and diversify participants as the trial continues to expand across North America.
Positive
- New site opened at University of South Florida
- 4 participants enrolled at the USF site
- CALMA remains randomized, double-blind, placebo-controlled
Negative
- Enrollment still early: only 4 participants at new site
- No efficacy or safety readouts reported in this announcement
Insights
IGC Pharma added a new Phase 2 CALMA site at the University of South Florida and has enrolled four participants, modestly accelerating recruitment.
IGC Pharma expands the randomized, double-blind, placebo-controlled CALMA trial by opening a new site led by Dr. Ram Bishnoi at the University of South Florida. The immediate effect is incremental recruitment capacity and added clinical oversight for the study of IGC-AD1 in agitation associated with Alzheimer’s disease; enrollment at the new site has already begun with four participants.
Key dependencies and risks include site-level enrollment rates, protocol adherence, and data quality; none of these are resolved simply by opening a site. The announcement contains no efficacy or safety data, so clinical or regulatory impact remains unmeasured. Operational risks such as slower-than-expected recruitment or protocol deviations could blunt the stated momentum.
Concrete items to watch are cumulative enrollment across all CALMA sites, any disclosed interim safety or efficacy updates, and site activation timelines. Expect relevant updates as enrollment milestones are reported and when the trial releases prospective interim analyses or topline results (monitor over the coming quarters to see whether this site materially shortens overall recruitment timelines).
POTOMAC, MD, 1734 / ACCESS Newswire / October 14, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced the expansion of its ongoing Phase 2 CALMA clinical trial evaluating investigational drug candidate IGC-AD1 for agitation in Alzheimer's disease. The trial has officially opened a new site at the University of South Florida's Department of Psychiatry and Behavioral Neurosciences, under the leadership of Principal Investigator Dr. Ram Bishnoi.
Enrollment at the new site has already begun, with four participants enrolled, marking an important step toward accelerating recruitment and advancing the timeline of the study. The addition of USF, a leading research and academic institution, underscores IGC Pharma's commitment to partnering with distinguished investigators to address the urgent, unmet needs of patients living with Alzheimer's disease.
"The opening of this site at the University of South Florida strengthens our ability to recruit diverse participants while ensuring the highest standard of clinical oversight," said Ram Mukunda, CEO of IGC Pharma. "USF brings a strong academic pedigree, deep expertise in behavioral neuroscience, and an established record in clinical research. With enrollment already underway, we're pleased to see continued momentum in advancing the CALMA trial."
The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of IGC-AD1 in reducing agitation in patients with Alzheimer's disease. With the addition of USF, CALMA continues to expand across multiple clinical sites in North America.
About the University of South Florida Department of Psychiatry and Behavioral Neurosciences
The Department of Psychiatry and Behavioral Neurosciences at the University of South Florida Morsani College of Medicine is a leading academic and clinical institution dedicated to improving mental health through an integrated mission of clinical care, education, and research. Founded in 1971 as USF's first residency training program, the department has achieved national and international recognition for its innovative approaches to treating mental, addictive, and behavioral disorders.
The department engages deeply with the local community through compassionate patient services including outpatient psychiatry, neurotherapies such as TMS and ECT, memory disorder clinics, and child development initiatives while also providing trainees with access to cutting-edge clinical trials and fellowships in key subspecialties.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With more than 30 patent filings, 12 patents granted and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
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 27, 2025, 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. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Contact Information:
Rosalyn Christian / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
FAQ
What did IGC announce about the CALMA Phase 2 trial on October 14, 2025?
How many participants are enrolled at the new USF site for IGC (NYSE:IGC)?
What is the design of the CALMA Phase 2 trial for IGC-AD1?
Will the USF site affect CALMA trial timing for IGC (IGC)?
Where is the new CALMA clinical site located for IGC-AD1?
