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- In the trial, elsiglutide reduced the incidence of chemotherapy-induced diarrhea in colorectal cancer patients receiving 5-FU based chemotherapy regimens, but not sufficiently to meet the primary endpoint for statistical significance
- Elsiglutide was observed to be safe and well tolerated in this patient population
- Helsinn is working on potential development options for elsiglutide to be decided following a full evaluation of the Phase IIb data set
- The top-line results from the elsiglutide Phase IIb trial have no effect on Zealand's financial guidance for 2016
COPENHAGEN, Denmark, May 4, 2016 -- Zealand announces that Helsinn has reported top-line results from its clinical Phase IIb dose-finding trial to assess the efficacy of elsiglutide in the prevention of diarrhea induced by chemotherapy in patients with colorectal cancer. The results showed a positive numerical but not statistically significant effect of elsiglutide on the primary endpoint, defined as the proportion of patients experiencing a maximum grade >= 2 diarrhea during the first cycle of chemotherapy. In the trial, elsiglutide demonstrated a favorable safety and tolerability profile.
Elsiglutide is a novel GLP-2 analogue invented by Zealand. Global development and commercialization rights to the compound are licensed to Helsinn for its therapeutic use in the field of cancer supportive care. Results from a previous clinical Phase IIa trial conducted by Helsinn have shown that elsiglutide reduces the severity of chemotherapy-induced diarrhea (CID) in colorectal cancer patients with a good safety profile. Diarrhea is one of the most debilitating side effects associated with cancer treatment and in particular chemotherapeutic agents containing 5-Fluorouracil (5-FU). No effective approved treatment for chemotherapy-induced diarrhea exists today.
Britt Meelby Jensen, President and Chief Executive Officer of Zealand, commented on the results: "Diarrhea is a significant burden for many cancer patients receiving 5-FU based chemotherapy, and there is no effective approved treatment available. We are impressed by Helsinn's commitment to the clinical development program with elsiglutide to help improve life for these patients, and we will now wait to get full understanding of Helsinn's intended path forward for the program."
