Sucampo To Stop Developing Cobiprostone For Oral Mucositis

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) announced that it will discontinue the development of its pipeline candidate, cobiprostone.

The candidate was being developed for the prevention of oral mucositis. The decision to discontinue was taken on the basis of the results of a prespecified futility analysis of a phase II study. The study evaluated an oral spray formulation of cobiprostone for the prevention of oral mucositis in patients who are undergoing radio chemotherapy for head and neck cancers.

The futility analysis showed that the clinical benefit of cobiprostone was insufficient to support the continuation of the study. However, there were no safety concerns and the safety profile was consistent with the previous studies.

In Apr 2016, Sucampo announced disappointing top-line data from a phase IIa study on cobiprostone in patients with proton pump inhibitor (PPI)-refractory non-erosive reflux disease (NERD) or symptomatic gastroesophageal reflux disease (sGERD). Consequently, the company had to discontinue the development of cobiprostone for PPI-refractory NERD/sGERD.

Meanwhile, Sucampo will focus on other candidates in its pipeline – label expansion of Amitiza and its partnership with Cancer Prevention Pharmaceuticals for the phase III candidate for familial adenomatous polyposis (FAP). We remind investors that the company entered into an option and collaboration agreement with Cancer Prevention Pharmaceuticals in Jan 2016, whereby the company was granted the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination product in North America. The product is currently in a phase III trial for the treatment of familial adenomatous polyposis (FAP).

We note that Amitiza is approved in the U.S. for three gastrointestinal indications – chronic idiopathic constipation (CIC) in adults, irritable bowel syndrome with constipation (IBS-C) in adult women and opioid-induced constipation (OIC) in adults suffering from chronic non-cancer related pain.

However, Sucampo is heavily dependent on Amitiza for growth and the company needs to deliver on its pipeline in order to reduce its dependence on a single product. Hence, any further delay in the development programs for candidates in its pipeline will adversely impact the prospects of the company.

Sucampo carries a Zack Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (NYSE:PFE) , Roche Holding (SIX:ROG) AG (OTC:RHHBY) and Johnson & Johnson (NYSE:JNJ) . While Pfizer sports a Zacks Rank #1 (Strong Buy), both Roche and Johnson & Johnson are Zacks Rank #2 (Buy) stocks.