American Marconi Wireless News - IGC Pharma Secures North American Composition Protection for IGC-AD1 as Phase 2 CALMA Enrollment Advances

With this allowance, patent No. 3,095,729, titled "Method and Composition for Treating CNS Disorders", IGC has secured composition protection for IGC-AD1 across key North American jurisdictions, reinforcing the long-term exclusivity around the formulation as the Phase 2 CALMA trial advances toward enrollment completion. The protection covers the specific low-dose combination central to IGC-AD1's therapeutic strategy.

The Company recently reported that approximately 70% of the planned enrollment in the ongoing randomized, double-blind, placebo-controlled Phase 2 CALMA trial has been completed. The Company believes that strengthening composition protection at this stage enhances both the durability and commercial positioning of IGC-AD1 as the program advances towards enrollment completion and subsequent database lock.

"Securing composition protection across North America strengthens the strategic foundation of IGC-AD1 at an important stage of clinical development," said Ram Mukunda, CEO of IGC Pharma. "As CALMA progresses toward its final enrollment phase, expanding patent coverage enhances both the durability and long-term commercial positioning of our Alzheimer's program and supports its potential commercial differentiation."

IGC-AD1 is a proprietary formulation that uses low doses of tetrahydrocannabinol (THC) combined with other ingredients. The Company believes that the multi-target formulation is differentiated from single-target therapeutic approaches as regulatory frameworks for cannabinoid-based therapeutics continue to evolve.

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 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. 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, and on Forms 10-Q filed with the SEC on August 14, 2025, and on November 14, 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
[email protected]
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

A.Malone--AMWN