IGC Pharma expands regulatory, AI data science capabilities ahead of Phase 2 CALMA readout
IGC•CALMA enrollment and regulatory support
CALMA has randomized 160 participants, with up to eight additional randomizations planned before enrollment closes to bolster the dataset.
The company engaged Italy-based contract research organization OPIS Research to support regulatory interactions with the European Medicines Agency.
Preparation for readout and partner discussions
The buildout is intended to support data quality work, regulatory readiness for potential FDA and EMA engagement, and preparation for partner discussions following the Phase 2 readout.
Expanded regulatory and data science capabilities
IGC Pharma is strengthening its regulatory, biostatistics, AI-enabled data science, and pharmaceutical development capabilities as it approaches enrollment closure for its Phase 2 CALMA Alzheimer’s trial, with topline results expected in Q4 2026.
