Mallinckrodt, CPP announce CPP FAP-310 trial did not meet primary endpoint

Cancer Prevention Pharmaceuticals, or CPP, and its partner Mallinckrodt announced that CPP’s pivotal phase 3 clinical trial, CPP FAP-310, of the investigational drug CPP-1X/sulindac in patients with familial adenomatous polyposis, or FAP, did not meet its primary endpoint. Specifically, the reduction of time to the first occurrence of an FAP-related event for the combination of CPP-1X and sulindac did not reach statistical significance compared to the two control arms. CPP FAP-310 included only active comparator arms and was the largest and longest study ever conducted in patients with FAP. Based on the topline results, Mallinckrodt does not plan to pursue the commercialization of the CPP-1X/sulindac program.

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