IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial

Rhea-AI Summary

IGC Pharma (NYSE American:IGC) has achieved 50% enrollment in its Phase 2 CALMA clinical trial for IGC-AD1, a treatment targeting agitation in Alzheimer's disease. The trial is a multicenter, double-blind, placebo-controlled, randomized study evaluating their proprietary formulation that combines low-dose THC with another active pharmaceutical ingredient.

The company has expanded its trial network to include six new research sites across Florida, Ontario, Rhode Island, Oklahoma, British Columbia, and Puerto Rico. IGC-AD1 shows promise through its multi-modal mechanism of action, potentially addressing both agitation symptoms and disease modification. Based on encouraging Phase 1 data and interim Phase 2 analysis, the company expects to complete the trial in early 2026.

Positive

• Reached 50% enrollment milestone in Phase 2 CALMA trial
• Encouraging data from Phase 1 and Phase 2 interim analysis showing reductions in agitation
• Geographic expansion with 6 new research sites added in 2025
• IGC-AD1 shows potential for both symptom treatment and disease modification
• Addresses large market with up to 76% of Alzheimer's patients affected by agitation

Negative

• Full trial completion not expected until early 2026
• Still in early clinical stages with no guaranteed FDA approval

Insights

Clinical Research Specialist

IGC Pharma's 50% enrollment milestone in Phase 2 Alzheimer's agitation trial shows promising progress with potential advantages over current treatments.

The 50% enrollment milestone in IGC Pharma's Phase 2 CALMA trial represents significant progress for their lead candidate IGC-AD1, a proprietary formulation combining low-dose THC with another pharmaceutical ingredient. This multicenter, double-blind, placebo-controlled, randomized trial is targeting one of Alzheimer's most challenging symptoms - agitation - which affects up to 76% of patients but remains poorly addressed by current therapies.

What makes this particularly noteworthy is the drug's multi-modal mechanism of action. Beyond potentially reducing agitation symptoms, preclinical and clinical evidence suggests possible disease-modifying effects through activity against the pathological hallmarks of Alzheimer's: beta-amyloid plaques, tau tangles, and mitochondrial dysfunction. This dual approach differentiates IGC-AD1 from existing treatments that merely address symptoms.

The company has strategically expanded its trial sites across diverse geographical locations including Florida, Ontario, Rhode Island, Oklahoma, British Columbia, and Puerto Rico. This expansion serves two critical purposes: accelerating recruitment and enhancing patient diversity, which strengthens the validity of eventual results. The company remains on track to complete enrollment in 2026 with trial completion targeted for early 2026.

Particularly encouraging is the mention of positive signals from both the Phase 1 trial and interim analysis of the current Phase 2 trial, suggesting early evidence of efficacy in reducing agitation. Current treatments for Alzheimer's agitation carry black box warnings or serious side effects, creating a substantial market opportunity for safer alternatives like IGC-AD1 if proven effective.

POTOMAC, MD / ACCESS Newswire / September 22, 2025 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage pharmaceutical company focused on therapies for Alzheimer's disease, today announced it has reached a key enrollment milestone of 50% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.

This milestone marks a significant step in advancing IGC-AD1, the Company's proprietary formulation that combines low concentrations of delta-9 tetrahydrocannabinol (THC) a naturally derived cannabinoid, with another active pharmaceutical ingredient. Preclinical and clinical evidence suggest that IGC-AD1 has a multi-modal mechanism of action, reducing agitation while also demonstrating potential disease-modifying effects through activity against beta-amyloid plaques, tau tangles and diminished mitochondrial functioning.

"CALMA is a multicenter, double blind, placebo controlled, randomized trial. Enrolling 50% of the target is a key achievement for the CALMA program," said Ram Mukunda, CEO of IGC Pharma. "Agitation affects up to 76% of Alzheimer's patients and remains one of the most disruptive and underserved symptoms, with current treatments carrying black box warnings or serious side effects. IGC-AD1 offers the potential for a safer, better tolerated therapy that could meaningfully improve quality of life for both patients and caregivers. With encouraging data, from our Phase 1 and from the Phase 2 interim analysis, showing reductions in agitation, we are building strong momentum toward full enrollment and remain on track with our goal of completing the trial in early 2026."

In 2025, new sites were added to broaden geographic reach and enhance patient diversity, including BayCare Health System (Florida), Hamilton Health Sciences (Ontario), Butler Hospital's Memory and Aging Program (Rhode Island), Lynn Health Science Institute (Oklahoma), Island Health's Royal Jubilee Hospital (British Columbia), and SCB Research (Puerto Rico). With enrollment accelerating across this network of leading centers, IGC Pharma remains on track to complete recruitment in calendar 2026.

To learn more about IGC Pharma and the CALMA trial, please visit www.igcpharma.com.

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 30 patent filings 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 and it quarterly report on Form 10-Q filed with the SEC on June 27, 2025, and August 14, 2025, respectively 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 is the current status of IGC Pharma's Phase 2 CALMA trial for Alzheimer's agitation?

IGC Pharma has reached 50% enrollment in its Phase 2 CALMA trial for IGC-AD1, with completion expected in early 2026. The trial is multicenter, double-blind, and placebo-controlled.

How does IGC-AD1 work in treating Alzheimer's agitation?

IGC-AD1 combines low-dose THC with another active pharmaceutical ingredient, showing a multi-modal mechanism that may reduce agitation while demonstrating potential disease-modifying effects against beta-amyloid plaques, tau tangles, and mitochondrial functioning.

What percentage of Alzheimer's patients could benefit from IGC Pharma's treatment?

Up to 76% of Alzheimer's patients experience agitation, which is currently an underserved symptom with existing treatments carrying black box warnings or serious side effects.

Where are IGC Pharma's new CALMA trial sites located?

In 2025, IGC added six new sites in Florida (BayCare Health System), Ontario (Hamilton Health Sciences), Rhode Island (Butler Hospital), Oklahoma (Lynn Health Institute), British Columbia (Royal Jubilee Hospital), and Puerto Rico (SCB Research).

What advantages does IGC-AD1 offer over current Alzheimer's agitation treatments?

IGC-AD1 potentially offers a safer, better-tolerated therapy compared to current treatments which carry black box warnings and serious side effects, while possibly providing disease-modifying benefits.