IGC Pharma Achieves 50% Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial

IGC Pharma has reached a 50% patient enrollment milestone in its Phase 2 CALMA clinical trial for Alzheimer's disease agitation treatment, IGC-AD1. The trial aims to enroll 300 patients and is expected to complete recruitment in 2026. IGC-AD1 combines low THC with another active pharmaceutical ingredient and has shown potential disease-modifying effects. The company remains on track to complete the trial and is advancing its pipeline of Alzheimer's and metabolic disorder treatments.

IGC Pharma, a clinical-stage biotechnology company, has reached a significant milestone in its Phase 2 CALMA clinical trial, with 50% of the target patient enrollment achieved. The trial, which aims to enroll 300 patients, is designed to evaluate the efficacy of IGC-AD1, a proprietary formulation combining low-dose THC with another active pharmaceutical ingredient, for the treatment of agitation in Alzheimer's disease IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial^[1].

The CALMA trial is a multicenter, double-blind, placebo-controlled, randomized study conducted across diverse geographical locations, including Florida, Ontario, Rhode Island, Oklahoma, British Columbia, and Puerto Rico. This strategic expansion of trial sites has accelerated recruitment and enhanced patient diversity, which is crucial for the validity of the study's results IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial^[1].

IGC-AD1 has shown promise through its multi-modal mechanism of action, which not only addresses agitation symptoms but also demonstrates potential disease-modifying effects. Preclinical and clinical evidence suggest that the drug may reduce agitation while also targeting pathological hallmarks of Alzheimer's such as beta-amyloid plaques, tau tangles, and mitochondrial dysfunction IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial^[1].

The company's CEO, Ram Mukunda, expressed optimism about the trial's progress, stating, "Enrolling 50% of the target is a key achievement for the CALMA program. Agitation affects up to 76% of Alzheimer's patients and remains one of the most disruptive and underserved symptoms, with current treatments carrying black box warnings or serious side effects. IGC-AD1 offers the potential for a safer, better tolerated therapy that could meaningfully improve quality of life for both patients and caregivers" IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial^[1].

IGC Pharma remains on track to complete enrollment by the end of 2026, with the full trial expected to be completed in early 2026. The company's pipeline includes other promising treatments for Alzheimer's and metabolic disorders, further highlighting its commitment to innovation in the biotechnology sector IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial^[1].

References
IGC Pharma Reports 50% Patient Enrollment Milestone in Phase 2 CALMA Alzheimer's Agitation Trial^[1] https://www.stocktitan.net/news/IGC/igc-pharma-reports-50-patient-enrollment-milestone-in-phase-2-calma-9u315u7830im.html