Helsinn and Zealand to advance elsiglutide for chemotherapy-induced diarrhea prevention

Privately-held Swiss pharmaceutical group Helsinn and its partner, Denmark-based Zealand Pharma A/S (Nasdaq: OMX: ZEAL), jointly announce that Helsinn has concluded a Phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhea in cancer patients with positive results. Elsiglutide is a potent and selective glucagon-like-peptide-2 (GLP-2) receptor agonist invented by Zealand and licensed to Helsinn for the development and use in Cancer Supportive Care.

In a randomized, double-blind, placebo-controlled Proof-of-Concept Phase IIa clinical study, Helsinn has assessed the efficacy and safety of elsiglutide for the prevention of chemotherapy-induced diarrhea. The study was conducted under an open Initial New Drug application with the US Food and Drug Agency in 19 European centers and enrolled 138 colorectal cancer patients. The patients were treated with 5-fluorouracil (5-FU) based chemotherapy (ClinicalTrials.gov Identifier: NCT01543451). Concurrently, Helsinn has completed a Phase Ib study, showing that elsiglutide is safe and tolerated at doses well above expectable therapeutic level.

Will move into Ph IIb