IGC Pharma Names IGC-AD1 Phase 2 Clinical Trial for Alzheimer's Agitation "CALMA" and Expands Recruitment Strategy

Rhea-AI Summary

IGC Pharma has officially named its Phase 2 trial for Alzheimer's agitation as CALMA (Calming Agitation in Alzheimer's). The trial addresses agitation, a condition affecting up to 76% of the 55 million Alzheimer's patients worldwide. The company has implemented an innovative recruitment strategy using geofencing technology and digital outreach through social media platforms.

The pilot recruitment campaign at select trial sites achieved a 200-300% increase in enrollment at a relatively low cost per lead. IGC Pharma is now expanding this strategy across all trial locations in the USA and Canada, targeting individuals within a 15-25-mile radius of clinical sites. The company aims to complete enrollment and the CALMA trial in the second half of 2025.

Positive

• Achieved 200-300% enrollment increase at pilot sites using geofencing technology
• Low cost per lead in recruitment campaign
• Trial addresses large market opportunity (76% of 55 million Alzheimer's patients)
• Clear timeline for trial completion (H2 2025)

Negative

• Trial completion not expected until second half of 2025
• Still in recruitment phase for Phase 2 trial

Innovative use of geofencing technology boosts enrollment at select sites

POTOMAC, MD / ACCESSWIRE / January 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") announced today that its ongoing Phase 2 trial for agitation in Alzheimer's disease has been officially named CALMA (Calming Agitation in Alzheimer's).

The trial's new identity reflects its mission to address agitation, a syndrome affecting up to 76% of the 55 million Alzheimer's patients worldwide that also adversely impacts the quality of life for both patients and their caregivers.

To accelerate enrollment across all clinical sites, IGC Pharma has implemented an innovative recruitment campaign leveraging geofencing technology and digital outreach through social media platforms. The recruitment strategy was piloted at select trial sites, where it achieved a remarkable 200-300% increase in enrollment at a relatively low cost per lead. Building on this success, IGC Pharma is expanding the campaign to the other trial locations, with the goal of completing enrollment and the CALMA trial in the second half of 2025.

By combining advanced outreach tools with CALMA's clear focus, IGC aims to enhance engagement with patients and caregivers while advancing toward key milestones in Alzheimer's treatment development.

Ram Mukunda, CEO of IGC Pharma, commented, "Recruitment is one of the most significant challenges in Alzheimer's clinical trials, and our use of innovative geofencing technology, wherein we digitally target individuals living in a 15-25-mile radius of a clinical site, has delivered impressive results, achieving a significant outreach and enrollment at select sites. Scaling this strategy across all trial locations, in the USA and Canada, we expect will accelerate our progress toward completing the CALMA trial and strengthen our ability to engage with patients and caregivers. The strategy is especially powerful in recruiting members of underserved communities. By leveraging advanced digital outreach tools, we aim to enhance trial awareness, streamline recruitment, and advance IGC-AD1's development as a transformative therapy for Alzheimer's agitation. This milestone represents another step forward in creating value for both patients and our shareholders."

About CALMA

The CALMA trial is a multicenter, double-blind, randomized, placebo-controlled Phase 2 study involving 164 participants. It is designed to evaluate the safety and efficacy of IGC-AD1, a partial CB1 receptor agonist with anti-neuroinflammatory properties, in treating agitation - a syndrome that accelerates cognitive decline and increases hospitalization rates among Alzheimer's patients.

Individuals can learn more about the Calma trial here: Facebook page

About IGC Pharma (dba IGC):

IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, NCT05543681). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions.

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 24, 2024, and on Form 10-Q filed with the SEC on August 7, 2024, 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.

Contact Information

Rosalyn Christian / Walter Frank
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on accesswire.com

FAQ

When will IGC Pharma complete the CALMA Phase 2 trial for Alzheimer's agitation?

IGC Pharma expects to complete enrollment and the CALMA trial in the second half of 2025.

What results has IGC's geofencing recruitment strategy achieved?

The geofencing recruitment strategy achieved a 200-300% increase in enrollment at select trial sites at a relatively low cost per lead.

How many Alzheimer's patients could potentially benefit from IGC's CALMA trial?

The trial addresses agitation affecting up to 76% of 55 million Alzheimer's patients worldwide.

What is the geographical scope of IGC's CALMA trial recruitment?

The trial recruitment is being conducted across locations in the USA and Canada, targeting individuals within a 15-25-mile radius of clinical sites.

What technology is IGC using to boost trial enrollment?

IGC is using geofencing technology and digital outreach through social media platforms to enhance trial recruitment.