Zealand Pharma A/S, a biotechnology company, and its partner, the Swiss pharmaceutical group Helsinn, have jointly announced that Helsinn concluded phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhoea 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 diarrhoea. The study was conducted under an open Initial New Drug (IND) application with the US Food and Drug Agency in 19 European centres 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.

Based on the results from the proof-of-concept study, Helsinn is now planning a phase IIb study to further evaluate the efficacy of elsiglutide as a novel therapy to prevent chemotherapy induced diarrhea in cancer patients.

In a comment to the news, David Solomon, president and chief executive officer of Zealand, said, “We are highly encouraged by the important progress our partner Helsinn is making with elsiglutide. Helsinn has a strong position in Cancer Supportive Care, and the promising findings from the Proof-of-Concept study leave further support for the potential of this Zealand invented peptide drug candidate as a novel preventative therapy that may offer cancer patients relief from chemotherapy induced diarrhea. Diarrhoea is a common and in many cases severe complication of chemotherapy, resulting in reduced quality of life, dehydration, hospitalization and in some cases non-optimal cancer treatment. We look forward to seeing elsiglutide be advanced to the next step in its development.”

Riccardo Braglia, chief executive officer of Helsinn Group, commented: “We are pleased of the promising advance of elsiglutide in an underserved medical area. The overall positive outcome of this Phase IIa clinical study is an important milestone in the development of an effective treatment for chemotherapy-induced diarrhea, a debilitating and potentially life threatening side effect of chemotherapy. This is another step forward in Helsinn’s commitment to working not only to improve the health of the Patient but to improve and maintain the overall quality of life of the Person.”

Terms of the agreement with Helsinn and Financial outlook for 2013

Under the agreement with Helsinn, Zealand is eligible to milestone payments of up to EUR 140 million in total, (of which EUR 14 million have been received) on elsiglutide plus royalties on global sales of the product. Zealand retains an option to obtain commercial rights to elsiglutide in the Nordic countries.

The promising results of phase IIa and Helsinn’s decision to advance elsiglutide into phase IIb development are not associated with a milestone payment and thus do not change Zealand’s financial outlook for 2013 as announced in the company’s Q1 2013 Interim report on May 15, 2013.

Elsiglutide is a novel, potent and selective glucagon-like-peptide-2 (GLP-2) agonist. GLP-2 is a peptide hormone produced primarily by the small intestine. It is secreted in response to food ingestion and acts by binding to the GLP-2 receptor, which is predominantly found in the gastrointestinal tract. GLP-2 plays a key role in intestinal growth and formation by promoting regeneration of the epithelial surface in this indication damaged by chemotherapy, the underlying cause of chemotherapy-induced diarrhoea.

Diarrhoea is one of the most common side effects of cancer treatment, resulting in significantly reduced patient’s quality of life and can have a profound effect on patient’s compliance with chemotherapy regimens and schedules leading even, in the most severe cases, to discontinuation of therapy and death.

The incidence and severity of Chemotherapy Induced Diarrhoea (CID) varies considerably with the nature and dose of the cytotoxic therapy, with regimens containing Irinotecan and 5-fluorouracil (5-FU) being associated with rates as high as 80 per cent. Current pharmacologic treatments are palliative at best and help to control and treat symptoms rather than to prevent the onset of diarrhoea.

Helsinn is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas.

Zealand Pharma is a biotechnology company specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities.