The FDA has granted Fast Track Status for CPP-1X/sul for FAP, a rare disease with no current effective treatment. An NDA and MAA were filed in June, 2020.
Fast Track designation is intended to facilitate development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.
FAP (familial adenomatous polyposis) is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. Our completed FAP-310 pivotal trial was a randomized, double-blind, Phase 3 trial designed to determine if the combination of CPP-1X plus sulindac is superior to CPP-1X or sulindac as single agents in delaying time to the first occurrence of any FAP-related event.
Fast Track designation makes CPP’s drug eligible for Accelerated Approval and Priority review if relevant criteria are met. The FDA also granted CPP-1X/sul orphan drug status for treatment of FAP.
All patients in the FAP-310 Trial have completed treatment, results have been presented and regulatory pathways are being pursued.
Familial adenomatous polyposis (FAP) is an inherited disorder characterized by cancer of the large intestine (colon) and rectum. People with the classic type of FAP may begin to develop multiple noncancerous (benign) growths (polyps) in the colon as early as their teenage years. Unless the colon is removed, these polyps will become malignant (cancerous). The average age at which an individual develops colon cancer in classic FAP is 39 years old.
In people with classic FAP, the number of polyps increases with age, and hundreds to thousands of polyps can develop in the colon. Also of particular significance are noncancerous growths called desmoid tumors. These fibrous tumors usually occur in the tissue covering the intestines and may be provoked by surgery to remove the colon. Desmoid tumors tend to recur after they are surgically removed. In both classic FAP and its attenuated variant, benign and malignant tumors are sometimes found in other places in the body, including the duodenum (a section of the small intestine), stomach, bones, skin, and other tissues. People who have colon polyps as well as growths outside the colon are sometimes described as having Gardner syndrome.
CPP’s lead combination therapy product CPP-1X/sul is being developed to minimize the occurrence and/or recurrence of problematic polyps and tumors associated with this debilitating disease.