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Sigmoid Pharma Initiates Phase II Trial for Leading Ulcerative Colitis Product

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Sigmoid Pharma Limited announced the initiation of a Phase II clinical trial to study the potential benefit of CyCol™ in the treatment of mild-to-moderate ulcerative colitis.

CyCol, an innovative oral cyclosporine formulation, also known as ciclosporin, is designed to release its contents directly into the colon, acting exclusively with its target tissue and avoiding the common side-effects often associated with conventional oral or injected cyclosporine formulations.

Ulcerative colitis is a chronic, inflammatory condition of the large bowel that affects up to one in 500 people, with onset of disease most common between the ages of 15 and 25. The available treatment options range from relatively mild aspirin-like drugs to powerful steroid and biological drugs depending on the relative severity of the condition. Patients who fail to respond to drug treatment often require surgery to remove all or part of the colon.

“The Sigmoid approach is first to understand if the pharmacology of existing ‘tried and tested’ drugs, marketed for a specific disease, makes them suitable to be developed as safe and effective treatments for other diseases,” said Dr. Ivan Coulter, a pharmacologist and CEO of Sigmoid Pharma. “During the process of researching and identifying a new use for a drug, we utilise Sigmoid’s proprietary oral drug delivery technologies to develop customised formulations adapted to optimally treat the identified disease.”

Limitations associated with existing drug treatments range from the limited efficacy of aspirin-like drugs to the potentially significant side effects associated with steroid and biological drugs; cyclosporine is an attractive potential alternative. When administered by injection or in high doses orally, cyclosporine has demonstrated effectiveness in the treatment of patients with severe colitis, including patients who have failed to respond to other drugs. However, the high doses required result in side effect profiles which limit use to that of a critical care rescue therapy. A lower dose of colon-specific cyclosporine as in CyCol may reduce side effects while broadening cyclosporine use to include mild-moderate as well as severe ulcerative colitis.

“We have taken cyclosporine, a well-established transplant anti-rejection drug with known potential to cause side-effects throughout the body and formulated it to target release specifically in the colon,” continued Coulter. “Therefore, CyCol has the potential to conveniently, effectively and safely treat ulcerative colitis, while avoiding potentially serious side-effects throughout the body.”

The trial is being performed under the direction of Professor Diarmuid O’Donoghue, a consultant gastroenterologist at St. Vincent’s University Hospital, Dublin. The trial aims to recruit approximately 100 patients. Each patient will receive either CyCol or a placebo for a four-week treatment period.

Based in Ireland, Sigmoid Pharma has developed two integrated oral drug delivery technology platforms, SmPill™ and LEDDS™. Through a technology bundling approach, both platforms can simultaneously enhance drug solubility, permeability and stability while achieving controlled or targeted release and is suited to delivery of small molecules and macromolecules, including vaccines.