Drug Development

Sucampo shutters development effort after lead drug flops in back-to-back studies

Back in April, when Sucampo’s lead experimental drug cobiprostone flunked its first mid-stage study, the Rockville, MD-based biotech stubbornly insisted that an ongoing study for another indication offered a whole new pathway forward. Today, that road came to an end, and the drug did too.

A futility analysis of the drug in a Phase IIa study of an oral spray formulation of cobiprostone for the prevention of oral mucositis in patients that are undergoing radio chemotherapy for head and neck cancer concluded that the study was another flop. And Sucampo says it’s moving on.

Shares in the biotech $SCMP are down 60% from their 12-month high. But the stock ticked down only slightly this morning, as many analysts had already written its drug off as a likely loser. Sucampo indicated it will turn to business development efforts to build the pipeline.

Peter Kiener, Sucampo CSO

Peter Kiener, Sucampo CSO

“Based on these results, we have decided to terminate the ongoing oral mucositis study and discontinue further development of cobiprostone,” said Peter Kiener, D. Phil, Chief Scientific Officer of Sucampo. “We will continue to focus on our life cycle management programs for lubiprostone, our partnership with Cancer Prevention Pharmaceuticals for its Phase III compound in the orphan indication familial adenomatous polyposis, and continuing to build a development pipeline through business development.”


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RAPS Regulatory Convergence 2017