In this case, more is just too much. The number of participants needed to determine a significant clinical outcome in 9 Meters Biopharma Inc.’s phase III of larazotide in treating celiac disease has grown too large to support the study. The company said an independent statistician’s interim analysis convinced it to take a step back and re-evaluate its options for developing the zonulin inhibitor in the indication.
9 Meters Biopharma Inc., of Raleigh, N.C., is newly born from the merger of Innovate Biopharmaceuticals Inc. and privately held RDD Pharma Ltd., of New York and Tel Aviv, Israel. About $22 million in new financing, led by Orbimed Advisors Ltd., and the signing of another merger into the new company of Richmond, Calif.-based Naia Rare Diseases Inc., which develops GLP-1 to treat short bowel syndrome, completes 9 Meters’ new path.