Camligo Trial Yields Mixed Results in Patients with Pouchitis

Camligo Trial Yields Mixed Results in Patients with Pouchitis
Atlantic Healthcare’s Camligo (alicaforsen enema) did not meet the primary endpoints of the Phase 3 clinical trial that aimed to evaluate the efficacy of the drug in patients with pouchitis. However, results do indicate benefit for a proportion of patients, and Atlantic Healthcare hopes to move forward with the regulatory approval process. This Phase 3 multi-center, double-blind, randomized controlled trial (NCT02525523) was conducted in 138 patients with chronic antibiotic refractory pouchitis who failed to respond appropriately to one or more courses of antibiotics. Pouchitis is the most common long-term complication of the surgical procedure known as ileal pouch anal anastomosis (IPAA), a surgery that patients with severe ulcerative colitis, a form of inflammatory bowel disease, must undergo. Pouchitis is characterized by inflammation, ulcers and frequent and urgent emptying of the bowel, often up to 20 times a day and night. The first line of treatment for pouchitis is antibiotic treatment, but a significant proportion of patients fail to respond. Alicaforsen is a type of drug known as an antisense oligonucleotide, designed to help reduce levels of ICAM-1,
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *