Helsinn Announces Top-Line Results of its Phase IIb Trial With Elsiglutide for the Prevention of Chemotherapy-induced Diarrhea in Colorectal Cancer Patients

LUGANO, Switzerland, May 4, 2016 /PRNewswire/ --

- 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

Helsinn, the Swiss pharmaceutical Group focused on building quality cancer care, announces 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.

Riccardo Braglia, Helsinn Group Vice-Chairman and CEO, commented on the results: 

"Obviously we are truly disappointed with the primary outcome of this trial and our team will now thoroughly analyse 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." 

The Phase IIb trial with elsiglutide was conducted at 45 centers across five EU countries (Germany, Czech Republic, Hungary, Poland and Bulgaria), Belarus, Russia and Ukraine and included a total of 497 colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI). Of the total number of patients, 13 received additional treatment with a monoclonal antibody and were not included in the primary trial population. All patients in the trial were randomized to treatment with one of three doses of elsiglutide (10 mg, 20 mg, or 40 mg) or placebo, administered subcutaneously once-daily over four consecutive days in the first two chemotherapy cycles. All patients were followed for three cycles.