Coronado Biosciences Announces Initiation of Phase 2 Study Evaluating TSO in Ulcerative Colitis

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BURLINGTON, Mass., Sept. 12, 2013 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today the initiation of a National Institutes of Health (NIH)-sponsored phase 2 study evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC). This multi-center study will be conducted by the Autoimmunity Centers of Excellence (ACE), which are funded through a multi-million dollar grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

"The ACE grant funded by NIAID, in collaboration with Coronado Biosciences, will allow us to investigate not only the clinical impacts of TSO in ulcerative colitis but to also explore numerous mechanistic aspects and interfaces between mucosal immunology, the gut microbiome and genetics of this chronic immune-inflammatory disease," stated Dr. Steven Hanauer, Principal Investigator of the study and Professor of Medicine and Clinical Pharmacology, Chief of Gastroenterology, Hepatology and Nutrition, and Director of The Logan Center for GI Clinical Research at the University of Chicago.

This phase 2 trial is a 12-week, randomized (1:1), double-blind, placebo-controlled clinical study designed to examine the safety and efficacy of TSO treatment in active left-sided UC and its effects on mucosal immune state and microbiota. The trial will randomize 120 patients to receive either TSO 7500 or placebo every two weeks for a total of six doses. The trial will evaluate the effect of TSO on clinical response of UC, intestinal mucosal immunological response, and inflammatory markers. The primary endpoint is clinical response, defined as a reduction in the Mayo score of ≥ 3 and ≥ 30% from baseline, along with either a decrease from baseline in the rectal bleeding sub-score of >1 point or an absolute rectal bleeding sub-score of 0 or 1 at Week 12.

"We are excited to have initiated the first phase 2 clinical trial studying TSO in ulcerative colitis and the third phase 2 clinical trial in our TSO program," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "This is another significant milestone for our clinical development program. This study further advances our inflammatory bowel diseases (IBD) program and compliments our lead indication, Crohn's disease. We completed enrollment of 250 patients in our phase 2 TRUST-I trial, which we announced on July 1, 2013, and expect to report data from two large phase 2 trials evaluating TSO in Crohn's disease during the fourth quarter of 2013: Top-line results from Coronado's TRUST-I trial in the U.S. and a second interim analysis from our development partner Dr. Falk Pharma's TRUST-II trial in Europe."

About Ulcerative Colitis

Inflammatory bowel disease (IBD) encompasses Crohn's disease (Crohn's) and ulcerative colitis (UC), chronic immune-mediated inflammatory diseases, in which the intestines (small and large intestines or bowels) become inflamed (red and swollen). This inflammation causes symptoms such as severe or chronic pain in the abdomen, diarrhea that may be bloody, weight loss, loss of appetite, bleeding from the rectum, joint pain, fever and skin problems. Symptoms can range from mild to severe and account for hundreds of thousands of physician visits and hospitalizations, annually, in the U.S. Treatments for IBD are aimed at inducing and maintaining symptomatic relief and healing of the inflammation (remissions). Once healed, therapies are directed to prevent recurrence (flare-ups) that are commonplace when acute treatments are stopped.

The most common forms of IBD are Crohn's disease and ulcerative colitis. In both Crohn's and UC, the mucosal inflammation generates large amounts of cytokines, immune messenger molecules such as IFN-y and TNF-α, which is why drugs blocking these cytokines have been shown to be effective in controlling symptoms. The main difference between the two diseases is the parts of the digestive tract they affect.

Ulcerative colitis affects the superficial layer of the large intestine and causes swelling and tiny open sores, or ulcers, to form on the surface of the lining. The ulcers can bleed and produce pus. In severe cases of ulcerative colitis, ulcers may weaken the intestinal wall so much that a hole develops. Ulcerative colitis can occur in people of any age, but it usually starts between the ages of 15 and 30. It affects men and women equally and appears to run in families, with reports of up to 20 percent of people with ulcerative colitis having a family member or relative with ulcerative colitis or Crohn's disease.

Standard therapy for the symptomatic treatment may include sulfasalazine, mesalazine, systemic and topical glucocorticoids, immunosuppressants like azathioprine or 6-mercaptopurine, and in severe cases also treatment with anti-TNF-α therapy, methotrexate, or cyclosporine as monotherapy or in combination with other agents. About 25-40 percent of patients are ultimately faced with surgery to remove sections of the diseased intestine. When the entire large intestine is removed, the patients can be completely cured. According to a 2012 Decision Resources report, in the U.S., the prevalence of ulcerative colitis in 2011 was 582,000 patients and there are about 1.1 million Americans living with IBD.

About TSO

TSO (Trichuris suis ova or CNDO-201), the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and pro-inflammatory cytokines. The use of TSO as a therapeutic is based on the "hygiene hypothesis" and numerous animal and human studies. TSO was chosen as the biological agent of choice because it is not a human pathogen, and is spontaneously eliminated from the body within several weeks after dosing.

In February 2012, the company reported positive results from a phase 1 clinical study of TSO in patients with Crohn's disease, where TSO was shown to be safe and well tolerated. The phase 1 trial was a multi- center, sequential dose, dose-escalation, double-blind, placebo-controlled study of 36 patients with Crohn's disease. In August 2012, Coronado initiated TRUST-I (TRichUris Suis ova Trial), a phase 2 clinical trial of TSO in patients with Crohn's disease in the United States, which is expected to be completed in the fourth quarter of 2013.

Multiple investigator-sponsored clinical trials of TSO for the treatment of Crohn's disease, ulcerative colitis and multiple sclerosis have been completed, in which TSO demonstrated benefit with regard to accepted outcome measurements of remission of disease, and was shown to be well tolerated. In an open-label clinical trial with 29 patients reported in GUT in April 2004, TSO was shown to induce clinical remission in over 72 percent of patients with Crohn's disease after 24 weeks of treatment using the Crohn's Disease Activity Index as the primary outcome variable. As reported in the American Journal of Gastroenterology in April 2005, in a double-blind, randomized placebo-controlled trial in 54 patients with ulcerative colitis, TSO was shown to produce statistically significantly more responders than those treated with placebo (43.3% vs. 16.7%, p=.04).

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The company's two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML), multiple myeloma and solid tumors. For more information, please visit www.coronadobiosciences.com.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the company's product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our ability to attract, integrate and retain key personnel; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; our dependence on third party suppliers; and competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

CONTACT: Lucy Lu, MD, Executive Vice President & Chief Financial Officer Coronado Biosciences, Inc. 781-652-4525; ir@coronadobio.com Marcy Nanus, Vice President The Trout Group, LLC. 646-378-2927; mnanus@troutgroup.com Susan Forman Dian Griesel Inc. 212-825-3210; susan@dgicomm.com

Source:Coronado Biosciences

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