Coronado Biosciences (NASDAQ:CNDO) announced that an investigator-sponsored Phase II clinical trial has begun evaluating the company’s novel immunotherapy in patients with ulcerative colitis (UC). CNDO-201, the company’s lead asset, is based on the hygiene hypothesis and uses a patented formulation of pig whipworm eggs (Trichuris suis ova) to regulate the immune system in patients with autoimmune conditions. The therapy has been tested in multiple disease areas and has demonstrated proof of efficacy and safety in humans in earlier trials. A safe and effective therapy for chronic autoimmune conditions like UC, Crohn’s disease, multiple sclerosis, and rheumatoid arthritis is badly needed, suggesting that if CNDO-201 succeeds in development, Coronado could have a multibillion product on its hands.
The Phase II UC study is being conducted at the NYU School of Medicine by Dr. Michael A. Poles, Associate Professor of Medicine, Gastroenterology, Microbiology and Pathology and Dr. P’ng Loke, Assistant Professor, Microbiology, from the NYU School of Medicine. The 18-patient trial will look at the drug’s mechanism of action in UC, with the potential to capture additional efficacy data in the condition. Results are expected in about a year, however, CNDO expects to see Phase IIb data from partner, Dr. Falk Pharma, in Crohn’s disease in mid-2013. The company will report second quarter results tomorrow. Shares could trade up on the pipeline advancement news.