Arizona Tribune - IGC Pharma Reaches 80% Enrollment in Phase 2 CALMA Trial, Entering Final Phase Ahead of Enrollment Completion and Data Readout

This milestone represents a significant step in advancing the program toward enrollment completion, expected in mid-2026, and positions the Company to progress toward database lock and topline results. Enrollment progress across the Company's US and Canadian clinical network continues to support consistent execution as the study enters its final phase.

Approaching a Defined Clinical Catalyst
"Reaching 80% enrollment marks an important milestone as we advance toward completion of the CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "We have entered the final phase of recruitment with strong momentum. Every patient enrolled brings us one step closer to evaluating the full potential of IGC-AD1. Our focus is now on 100% enrollment and preparing for the data readout that could potentially redefine the treatment landscape for Alzheimer's disease."

Enrollment completion represents the primary operational gating step ahead of clinical data readout. As a randomized, double-blind, placebo-controlled study, efficacy outcomes are not analyzed on an ongoing interim basis in order to preserve trial integrity.

Final Phase of Execution
As the trial progresses through the final phase of recruitment, the Company continues to benefit from:

• Sustained enrollment momentum across a diversified US and Canadian clinical network

• Imminent Catalyst: Completion of enrollment in mid-2026 sets the stage for the highly anticipated Phase 2 topline results.

• Unmet Need: While the first medication for agitation was recently approved, the market remains largely underserved. With agitation affecting up to 76% of Alzheimer's patients, IGC is positioning as a Next-Generation Disruptor in a multi-billion-dollar CNS market where the demand for diverse and safer treatment options remains critical.

Advancing Toward a Defined Clinical Catalyst
IGC-AD1 is an investigational therapy being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to assess both safety and efficacy in patients with Alzheimer's disease experiencing agitation.

Agitation is a devastating neuropsychiatric symptom that often leads to premature institutionalization and severe caregiver burnout. Each successive enrollment reduces operational risk and supports IGC's progression toward a defined clinical data catalyst that could help transform the lives of patients and caregivers worldwide. With enrollment now at approximately 80%, the Company believes the CALMA trial is entering its final operational phase ahead of a defined clinical readout.

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 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 a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.

Contact Information:
Walter Frank / John Nesbett
IMS Investor Relations
[email protected]
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

W.Morales--AT