Zealand and drug partner Helsinn have missed the primary endpoint for reducing diarrhea in colon cancer patients, chalking up another failed study in as many months for the Danish biotech.
The top-line results from the elsiglutide Phase IIb trial showed the experimental drug, while reducing the incidence of chemotherapy-induced diarrhea in colorectal cancer patients, missed its primary endpoint as it didn’t reach statistical significance. The two companies said there were however no safety problems associated with the study.
Copenhagen, Denmark-based Zealand helps develop elsiglutide (which it discovered) with Swiss cancer company Helsinn, which owns the certain commercial and development rights to the treatment in this setting.
GLP-2 has previously been tested in short bowel syndrome and intestinal failure--but the companies were hoping it may also be effective for side effects of cancer drugs.
Though not often talked about, diarrhea is in fact one of the most debilitating side effects associated with cancer treatment, and there is currently no approved treatment for chemotherapy-induced diarrhea, according to the companies.
Helsinn said in a statement that it is “working on potential development options for elsiglutide to be decided following a full evaluation of the Phase IIb data set.”
Riccardo Braglia, Helsinn Group vice-chairman and CEO, said in a statement: “Obviously we are truly disappointed with the primary outcome of this trial and our team will now thoroughly analyze all the trial results. We will then evaluate the best path forward for this program, while acting, as we always do at Helsinn, in the best interest of patients and with our focus on improving the everyday lives of cancer patients.”
Zealand said in a statement that the flubbed trial results will have no effect on its financial guidance for this year.
But it’s already been a tough few months for the Danish biotech, as back in March it announced that another drug--danegaptide--missed the primary endpoint in a Phase II cardiac reperfusion injury trial. The failure of the study, which was viewed as a long shot by some analysts, led to Zealand focusing its resources on other areas of its pipeline.
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