IGC Pharma reported that it has reached a 65% enrollment milestone in its Phase 2 CALMA trial, enrolling 107 of the 164 planned participants for the study of IGC‑AD1 in agitation associated with Alzheimer’s disease. The milestone was achieved before the company’s projected early‑2026 read‑out and confirms that the trial is on track to meet its statistical power requirements.
The CALMA trial is a multicenter, double‑blind, randomized, placebo‑controlled study that began enrolling in early 2024. With 107 participants now enrolled, the study is 65% complete and is progressing ahead of the original schedule that had anticipated 50% enrollment by the end of September 2025. The trial’s early‑2026 read‑out is now more likely to be delivered on time, which is critical for the company’s regulatory strategy and potential partnership discussions.
Enrollment progress is a key driver of investor confidence, especially given IGC Pharma’s limited financial resources and tight cash runway. Achieving the milestone ahead of schedule reduces the risk of costly delays and demonstrates efficient site activation and patient recruitment, which are often the biggest bottlenecks in Alzheimer’s trials. The company’s focus on maintaining a lean operating model while advancing a high‑potential asset is a positive signal to stakeholders who are watching the company’s cash burn closely.
IGC Pharma’s hybrid recruitment strategy has been a cornerstone of the enrollment success. Approximately 25% of participants were recruited through targeted social‑media campaigns, while the remaining 75% were enrolled at clinical sites across the United States and Canada. This data‑driven approach has accelerated enrollment and broadened the geographic footprint, mitigating the risk of site‑level slowdowns that can derail timelines in multi‑country studies.
CEO Ram Mukunda emphasized that the enrollment milestone “underscores the robustness of our recruitment strategy and the strong interest from patients and caregivers in a therapy that could address a significant unmet need.” He added that the company remains focused on gathering safety and efficacy data in the coming months, while continuing to manage cash burn prudently to support the trial’s completion and potential regulatory submission.
The milestone also positions IGC Pharma favorably within a competitive landscape of Alzheimer’s agitation therapies. With over 76% of patients experiencing agitation, a safe and effective treatment could capture a sizable market share. The company’s progress in the CALMA trial strengthens its case for future partnership or investment opportunities, while the hybrid recruitment model may serve as a best‑practice example for other biopharmaceuticals facing similar enrollment challenges.
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