IGC Pharma expands regulatory, AI data science capabilities ahead of Phase 2 CALMA readout
Reuters2026/08/11 12:32- 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.
- 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.
- 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.
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