American Marconi Wireless News - IGC Pharma Completes Enrollment in Phase 2 CALMA Alzheimer's Trial; Topline Results Expected Q4 2026

• Enrollment complete; final participant dosing expected to conclude in early November; topline results expected Q4 2026

CALMA achieved target enrollment with 168 participants randomized, including planned over-enrollment designed to strengthen the evaluable dataset for end-of-treatment, secondary, and exploratory analyses. Following the protocol-defined six-week treatment period, final participant dosing is expected to complete in early November, after which the Company expects to proceed toward database lock, unblinding, and topline analysis, with topline results expected in the fourth quarter of 2026.

"With target enrollment complete, CALMA has officially transitioned from recruitment to the final stage ahead of topline results," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "Our focus is now on patient follow-up and database lock as we prepare this 168-patient dataset for rigorous scientific and regulatory evaluation and potential next-stage development."

CALMA is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating IGC-AD1, an investigational oral solution dosed twice daily for six weeks, for agitation in Alzheimer's dementia. The primary endpoint is change in agitation from baseline to week six on the Cohen-Mansfield Agitation Inventory. The trial was conducted across clinical sites in the United States and Canada, including academic and specialty centers such as Baycrest Academy for Research and Education, Butler Hospital - Memory and Aging Program, Hamilton Health Sciences, McGill University, and Miami Jewish Health.

The enrolled population had an average age of approximately 78 years, reflecting an older Alzheimer's dementia population, and approximately 53% of participants were female. Based on available race data, approximately 77% of participants were White, 16% were Black or African American, and the remaining participants identified as other races or were not listed.

Agitation is one of the hardest symptoms of Alzheimer's dementia for families and caregivers to manage. It can contribute to emergency care, caregiver distress, earlier placement in residential care, and increased healthcare costs. IGC-AD1 is being developed as a potential treatment option for this high-burden patient population.

The Data Safety Monitoring Committee has conducted periodic safety reviews and at each review to date, has recommended that the trial continue without modification. The Company remains blinded to treatment assignment. As of the Company's most recent safety reporting, blinded safety monitoring had not identified any treatment-related serious adverse events as related to study treatment. Safety data remain subject to final review and analysis after database lock and unblinding.

"Completing enrollment is a defining clinical milestone for IGC Pharma," Mr. Mukunda continued. "We are grateful to the participants, caregivers, investigators, and clinical teams who made CALMA possible, and we look forward to reporting topline results."

About IGC-AD1 and CALMA

IGC-AD1 is IGC Pharma's lead investigational therapeutic candidate for agitation in Alzheimer's dementia. CALMA is a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of IGC-AD1 in this population. The trial's primary efficacy endpoint is change in agitation as measured by the Cohen-Mansfield Agitation Inventory, a commonly used clinical assessment of agitation behaviors in dementia.

About IGC Pharma

IGC Pharma, Inc. (NYSE American: IGC) is a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease and other indications. The Company's lead asset, IGC-AD1, is being evaluated in the Phase 2 CALMA clinical trial for agitation in Alzheimer's dementia. The Company is also developing AI-enabled tools intended to support biomedical discovery, data harmonization, and clinical development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Phase 2 CALMA trial, final participant dosing, participant visits and follow-up, database lock, unblinding, data analysis, anticipated timing of topline results in the fourth quarter of 2026, clinical and regulatory development plans for IGC-AD1, safety monitoring, AI-enabled data science capabilities, potential next-stage development planning, and future clinical milestones.
These statements are based on current expectations, estimates, and projections and involve known and unknown risks and uncertainties that could cause actual results, timelines, or outcomes to differ materially from those expressed or implied. Such risks and uncertainties include, among others, risks related to clinical trial timelines and outcomes; patient follow-up; data quality, reconciliation, and evaluability; database lock and statistical analysis; safety and efficacy results; regulatory feedback or approvals; financing needs; third-party service providers; software development and validation; and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-KT and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact Information
Andres Sanchez
Investor Relations
[email protected]
+1 301-983-0998 / +1 (202) 569-2566

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

F.Dubois--AMWN