TP-252: A Novel Derivative of Eicosapentaenoic Acid
A preclinical asset with clinical proof of concept in multiple GI indications.
TP-252 is a novel salt comprised of eicosapentaenoic acid as the free acid (EPA-FFA) and a mineral amino acid. TP-252 dissociates completely in biological fluids into these two well-characterized, safe entities to provide delivery of EPA-FFA. TP-252 provides key advantages over EPA-FFA as the natural oil to enable rapid commercial development as a prescription drug. We are targeting two GI indications for TP-252 based on Phase II clinical studies with EPA-FFA demonstrating it is well-tolerated and effective.
TP-252 for treatment of ulcerative colitis
The lead target indication for TP-252 is adjunct therapy to 5-ASAs for maintenance of remission in ulcerative colitis patients with a history of mild to moderate disease.
Ulcerative colitis, a type of inflammatory bowel disease, is characterized by inflammation and ulceration of the colon and rectum, and causes abdominal pain, bleeding, and diarrhea. Our focus on this indication is based on clinical data showing that EPA reduces relapse rates in ulcerative colitis patients who have been in stable remission but are at increased risk of relapse.
TP-252 for treatment of familial adenomatous polyposis (FAP)
In addition, we are developing TP-252 for treatment of familial adenomatous polyposis (FAP), a rare genetic disease that causes proliferation of colon polyps in teenagers.
This disease is usually treated with prophylactic colectomy, typically before age 20, to reduce the risk of colorectal cancer. There are currently no drugs approved for the treatment of FAP. While surgery is necessary for long-term survival, it causes significant co-morbidities and psycho-social issues affecting the health and quality of life of adolescent FAP patients.
EPA-FFA, the active ingredient in TP-252, has been shown clinically to control increases in colorectal polyp burden in FAP patients. TP-252 is designed to provide continuous management of polyp burden in conjunction with endoscopic surveillance. Improved management of disease progression may enable young FAP patients to delay surgery until they are better situated in life to handle the traumatic physical effects and emotional burden of colectomy.