Sucampo 0-2 as it ditches cobiprostone studies after second failure


Sucampo Pharmaceuticals ($SCMP) said it will kill off development of its lead experimental drug cobiprostone after another midstage trial showed it produced no clinical benefit, this time in oral mucositis.

The MD-based biotech said in a brief statement that the decision to terminate the program was made after it undertook a futility analysis of a Phase IIa study of an oral spray version of cobiprostone. The drug was seeking to prevent oral mucositis (which causes mouth ulcers) in patients receiving radio-chemotherapy for head and neck cancer.

Sucampo said that, after looking at the data, it was clear that the clinical benefit of cobiprostone in this setting “was insufficient to support continuation of the study.” It added that there were however no safety concerns within the trial.

The company had bet big on this trial working after announcing back in April that the candidate had flubbed its first Phase IIa trial after it failed to meaningfully improve heartburn symptoms for proton pump inhibitor-resistant nonerosive reflux disease, or symptomatic gastroesophageal reflux disease.

The biotech was adamant at the time that the chloride channel activator wasn’t dead, saying it was confident that its other Phase IIa data for oral mucositis would come good. Today, however, it had to admit defeat.

"Based on these results, we have decided to terminate the ongoing oral mucositis study and discontinue further development of cobiprostone,” explained Peter Kiener, CSO of Sucampo.

Kiener said the biotech’s focus will now shift to its programs for the Takeda-partnered constipation drug lubiprostone (also known as Amitiza), as well as its partnership with Cancer Prevention Pharmaceuticals for its Phase III compound in the orphan indication familial adenomatous polyposis.

This is a major hit to the company given that this was its lead drug, and analyst Jason Gerberry at Leerink said back in April that the cobiprostone study was probably its most important pipeline catalyst for 2016.

In premarket trading, the biotech’s shares were down by more than 5% with a market cap of just $530 million.

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