- 9 Meters Biopharma Inc NMTR completed a pre-specified interim analysis for the Phase 3 study of larazotide for patients with celiac disease who continue to experience gastrointestinal symptoms while adhering to a gluten-free diet.
- Based on consultation with the independent statistician, 9 Meters has determined that the additional number of patients needed to determine a significant clinical outcome between placebo and larazotide is too large to support trial continuation.
- The interim analysis included the first approximately 50% of the initial target enrollment and followed the completion of the 12-week double-blind efficacy portion of the study.
- “We plan to continue to analyze the data over the coming weeks to determine if other individuals or groups of celiac symptoms might benefit from treatment with larazotide,” said Patrick Griffin, Chief Medical Officer of 9 Meters.
- “Completing the analyses and engagement with FDA will determine further plans for larazotide to treat celiac disease,” he added.
- Price Action: NMTR shares are down 54.08% at $0.24 during the market session on the last check Tuesday.
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