Sigmoid aims to be a global leader in the development of gastrointestinal and immunological therapeutics. Sigmoid has developed a number of product concepts that are different stages of development and are described in the table below.
Sigmoid’s lead product, CyCol®, harnesses the powerful efficacy of the known immunosuppressive drug, cyclosporine in a safer format by targeting drug release towards the site of diseased tissue in the colon of patients with ulcerative colitis, and is forecast to achieve global annual peak sales in excess of $0.5 billion.
Sigmoid plans to initiate Phase 3 trials in North America and Europe. The goals and design of this study and the path to market was discussed with the US Food and Drug Administration and a number of European National Agencies.
CyCol® will be developed for induction of remission (resolving inflammation) and maintenance of remission (preventing future inflammation) in moderate to severe ulcerative colitis patients.
The moderate to severe patient segment represents the fastest growing market segment, with double-digit annual growth forecast. It is estimated that there are 1.4 million ulcerative colitis patients in the seven major markets of the United States, Japan, the United Kingdom, France, Germany, Spain and Italy. Of those, approximately 40% are estimated to have active disease classified as moderate to severe at any given time. Currently, only two drugs, Remicade® and Humira®, both TNFα monoclonal antibodies, are approved for moderate to severe ulcerative colitis in the United States. These high cost, injected therapies are not effective in all patients and have a number of known side effects. There is a clear opportunity for a convenient, orally administered, effective and safer alternative for this patient group.
Sigmoid has completed a number of trials of CyCol® including two Phase 1 clinical trials of the pharmacokinetics of CyCol® and a Phase 2 clinical trial of CyCol® in more than 100 mild to moderate patients in the United Kingdom and Ireland. CyCol® was shown to be safe and well tolerated over the four weeks treatment and four weeks follow up periods.