Sigmoid Pharma Announces CyCol Data Presentation at the British and Irish Gastroenterology Spring Meeting
- Lead Investigator Professor Diarmuid O Donoghue presented encouraging evidence of the benefit of CyCol in more than 100 patients from Ireland and England
- Follow on phase 2b trial design underway for moderate to severe ulcerative colitis patients
- US FDA and European Regulators have reviewed proposed regulatory strategy
DUBLIN, Ireland. April 11, 2013 Sigmoid Pharma, Ltd, a privately-owned, specialty pharmaceutical and drug delivery company registered in Ireland, announces that Professor Diarmuid O Donoghue presented data from the Sigmoid-sponsored phase 2a clinical trial of CyCol at the British and Irish Gastroenterology Spring meeting at the Belfast Waterfront today at 11:40 am. www.isge.ie
CyCol is Sigmoids proprietary oral formulation of solubilised cyclosporine targeted to the site of action in the colon to offer potential for a new safe and effective approach to treat and manage ulcerative colitis. In 2012, Sigmoid announced top-line results from a multi-centre trial in Ireland and the United Kingdom that enrolled 118 patients. Professor O Donoghue will present the results of the clinical trial to a medical audience for first time. Results in this short four week treatment period that used a once-daily, low dose regimen provided encouraging proof of principle that met the safety endpoint of no difference between treatment and placebo arms. A numerical difference was observed in efficacy between treatment and placebo arms, with the remission rate in CyCol group of 13.2% more than double the remission rate of 6.3% in the placebo group and the patient response rate, measured as a reduction in Disease Activity Index score 3 in CyCol group of 30.4% compared to a reduction in the placebo group of 18.8%. A post-hoc responder analysis showed that 28.3% of patients on CyCol had a DAI score reduction of 3 compared to only 14.1% of patients on placebo (p=0.0684.)
Professor ODonoghue remarked; Cyclosporine has been used for the past 20 years to treat ulcerative colitis patients who have failed to respond to other therapies. It has been proven to be one of the most effective therapies available for patients with severe ulcerative colitis. However, due to side effect concerns, the use of cyclosporine has been limited to 3 months. As CyCol appears to be safe, it may be possible to use cyclosporine as a therapeutic option for both short term and long term treatment of ulcerative colitis. The recent clinical study has paved the way for more extensive studies, which if successful could see CyCol approved for the treatment of moderate to severe colitis as early as 2017.
Sigmoid has evaluated the results of the phase 2a clinical trials with the primary investigators and other renowned international gastroenterology thought leaders and plans to progress development of CyCol for the induction of remission in moderate to severe ulcerative colitis and the maintenance of remission in people with ulcerative colitis
In October and November 2012, Sigmoid attended formal regulatory meetings with the U.S. Food and Drug Administration (FDA) and three national European agencies to review the proposed clinical development plan and seek scientific advice regarding the regulatory strategy for CyCol. Sigmoid will pursue a section 505(b)(2) filing in the United States if the two planned confirmatory clinical trials demonstrate meaningful, statistically significant efficacy and acceptable safety.
Currently, only two drugs are approved for moderate to severe ulcerative colitis, both of which are biologics that are administered by injection. The moderate to severe segment represents the highest unmet clinical need impacting between 25-45% of the ~1.4 million people with ulcerative colitis in the seven major markets of the US, Europe and Japan. In both the clinical and commercial contexts, the moderate to severe segment is experiencing the greatest growth. Decision Resources recently forecast that sales of ulcerative colitis treatments in the seven major markets would double over the next decade, reaching $3.7 billion by 2021. Sigmoid plans to file an Investigational New Drug application (IND) and Clinical Trial Applications (CTAs) in 2013 to conduct an appropriately designed, placebo-controlled trial to assess the safety and efficacy of two doses of CyCol over 8 weeks in more than 300 moderate to severe ulcerative colitis patients at leading clinical centres in the US and Europe.
About SmPill oral drug delivery technology
Sigmoid Pharma has developed an innovative oral drug delivery technology called SmPill; a modular, flexible and powerful approach to the challenges of formulating active pharmaceutical ingredients. Uniquely, SmPill enables the integration into one delivery system mechanisms that enhance solubility, permeability, stability and targeting. SmPill is broadly applicable to all molecule types including small molecules, and large molecules such as proteins, peptides and vaccines. SmPill technology is suitable for all BCS classes from potent, highly-soluble, highly-permeable drugs to poorly-soluble, poorly-absorbed molecules, including unique targeted release combination variations.
About Sigmoid Pharma Ltd.
Sigmoid Pharma is a privately-funded, development-stage, specialty pharmaceutical and drug delivery company. Sigmoid Pharma was founded in 2003, and has developed a unique oral drug delivery technology, SmPill, with broad applicability to the challenges of formulating active pharmaceutical ingredients. Sigmoid Pharma has built a pipeline of therapeutic product candidates, including its lead product, CyCol for moderate to severe ulcerative colitis, CyCron for Crohns Disease, and AllCol, which has been orphan designated by the FDA for the prevention and treatment of Graft versus Host Disease. Sigmoid is advancing a number of oral vaccine candidates in collaboration with international antigen and adjuvant companies. For additional information please visit http://www.sigmoidpharma.com
SOURCE: Sigmoid Pharma Limited
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