American Marconi Wireless News - IGC Pharma Strengthens Regulatory Readiness as Phase 2 CALMA Alzheimer's Trial Approaches Enrollment Closure and Q4 Topline Readout

CALMA has randomized 160 participants to date. IGC Pharma expects to close enrollment after up to additional participants, marking a key final enrollment milestone before patient follow-up, database lock, unblinding, and topline analysis. This final planned over-enrollment phase is intended to strengthen the dataset for end-of-treatment, secondary, and exploratory analyses.

The Company is strengthening these capabilities to support clinical data review, AI-assisted data quality activities, regulatory preparedness for potential engagement with the U.S. Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), and strategic evaluation by potential pharmaceutical partners following completion of the Phase 2 CALMA trial. As part of this readiness effort, IGC Pharma has engaged OPIS Research, a full-service global contract research organization founded in Italy, to support EMA-related regulatory interactions.

"CALMA is moving through its final enrollment phase, and our focus is now on execution, data quality, and readiness for the next set of milestones," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "With 160 participants randomized and up to eight additional randomizations expected before enrollment closure, we are preparing the CALMA dataset for rigorous scientific, regulatory, and strategic evaluation following completion of the Phase 2 trial. If supported by the CALMA results, we believe these activities could support a more efficient transition from clinical execution to data analysis, regulatory planning, and potential next-stage development."

IGC-AD1 is IGC Pharma's lead investigational therapeutic candidate for agitation associated with Alzheimer's dementia, a condition that creates significant burden for patients, caregivers, clinicians, and healthcare systems. CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate IGC-AD1 in this population.

As CALMA approaches enrollment closure and expected topline readout in the fourth quarter of 2026, IGC Pharma continues advancing both its Alzheimer's therapeutic pipeline and AI-enabled development capabilities in preparation for one of the Company's most significant clinical milestones to date.

About IGC Pharma, Inc. (dba IGC):

IGC Pharma, Inc. (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop treatments for Alzheimer's disease and metabolic disorders. The Company's lead asset, IGC-AD1, is an investigational therapy currently being evaluated in the Phase 2 CALMA trial for agitation associated with Alzheimer's dementia. The Company's pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunction. IGC Pharma integrates AI to support drug discovery, clinical trial optimization, and patient targeting.

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 Company's expected Phase 2 topline results, anticipated enrollment closure, patient follow-up, database lock, unblinding, topline analysis, regulatory preparedness, AI-enabled data science activities, potential engagement with regulatory authorities, potential strategic evaluation by pharmaceutical partners, and potential next-stage development of IGC-AD1. 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, maintain data quality, complete database and statistical analysis activities, achieve expected data readout timelines, obtain regulatory feedback or approvals, successfully implement regulatory, biostatistical, AI-enabled data science, and strategic development capabilities, attract or complete strategic evaluations or partnerships, 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. The Company undertakes no obligation to update these statements except as required by law.

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

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

P.Silva--AMWN