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IGC Pharma Adds Ichor Research as New Site for CALMA Phase 2 Alzheimer's Trial

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IGC Pharma (NYSE American: IGC) announced the addition of Ichor Research in Syracuse, New York, as a new clinical trial site for its ongoing Phase 2 CALMA trial. The study evaluates IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease patients.

The trial, designed as a randomized, double-blind, placebo-controlled study, will be led by Principal Investigator Dr. Karl F. Hafner, M.D. at the new site. The CALMA trial aims to assess the safety and efficacy of IGC-AD1 in reducing agitation symptoms, which are among the most common and distressing behavioral symptoms in Alzheimer's patients.

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Positive

  • Addition of new clinical trial site expands patient access and recruitment potential
  • Immediate enrollment initiation at the new site indicates operational readiness
  • Experienced Principal Investigator with expertise in neurodegenerative conditions

Negative

  • None.

News Market Reaction

+5.61% 1.6x vol
3 alerts
+5.61% News Effect
+9.7% Peak Tracked
+$2M Valuation Impact
$40M Market Cap
1.6x Rel. Volume

On the day this news was published, IGC gained 5.61%, reflecting a notable positive market reaction. Argus tracked a peak move of +9.7% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $40M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

POTOMAC, MD / ACCESS Newswire / September 29, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease. The new site, Ichor Research, located in Syracuse, New York, is led by Principal Investigator Dr. Karl F. Hafner, M.D.

Dr. Hafner brings years of experience in clinical research and patient care, particularly in the field of neurodegenerative conditions. Ichor Research began enrolling eligible participants for the CALMA trial immediately.

The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of IGC-AD1 in reducing agitation symptoms in individuals living with Alzheimer's disease. Agitation is one of the most prevalent and distressing behavioral symptoms in Alzheimer's patients, often accelerating disease progression and increasing caregiver burden.

"We are proud to partner with Ichor Research as part of our commitment to expand access to innovative treatment options for patients and caregivers," said Ram Mukunda, CEO of IGC Pharma. "Dr. Hafner, and the team at Ichor bring valuable expertise that will help advance the CALMA trial."

Contact Information:

Kristen Stebbins
VP of Clinical Trial Operations
1101 Erie Blvd East, Suite 201
Syracuse, NY 13210
Office: 315-904-5004
Email: kstebbins@ichorlifesciences.com

To learn more about IGC Pharma and the CALMA trial, please visit: Link

About Ichor Research

Research Central LLC, operating as Ichor Research, is a clinical research organization based in Syracuse, New York, with expertise in clinical trials for Alzheimer's disease. Ichor Research is dedicated to overcoming the unique challenges involved in Alzheimer's disease clinical trials, advancing medical innovation through high-quality, patient-focused clinical trials. Under the leadership of experienced clinical trials experts Lisa Sonneborn and Kristen Stebbins, Ichor collaborates with industry sponsors to evaluate novel treatments across a variety of therapeutic areas. The site is committed to ethical research practices, scientific integrity, and improving outcomes for patients through the development of evidence-based medical therapies.

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 filed with the SEC on June 27, 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
igc@imsinvestorrelations.com
(203) 972-9200

SOURCE: IGC Pharma, Inc.



View the original press release on ACCESS Newswire

FAQ

What is the purpose of IGC Pharma's CALMA Phase 2 trial?

The CALMA Phase 2 trial aims to evaluate the safety and efficacy of IGC-AD1 in reducing agitation symptoms in Alzheimer's disease patients.

Where is IGC Pharma's new clinical trial site located?

The new trial site, Ichor Research, is located in Syracuse, New York.

Who is leading IGC Pharma's CALMA trial at the new Ichor Research site?

Dr. Karl F. Hafner, M.D. is serving as the Principal Investigator at the Ichor Research site.

What type of study design is IGC Pharma using for the CALMA trial?

The CALMA trial is designed as a randomized, double-blind, placebo-controlled study.

Why is IGC Pharma targeting agitation in Alzheimer's patients?

Agitation is one of the most prevalent and distressing behavioral symptoms in Alzheimer's patients, often accelerating disease progression and increasing caregiver burden.
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