GLOSTRUP, DENMARK--(Marketwire - February 03, 2009) -
Copenhagen, 3 February 2009 Announcement no. 1, 2009
Summary:
Zealand Pharma advances ZP1848, a Glucagon-Like Peptide-2 (GLP-2) agonist, into Phase I clinical trials. ZP1848, a peptide which incorporates Zealand’s proprietary SIP® technology is developed as a therapy for the prevention and treatment of Crohn’s Disease.
The Phase I study is a double-blind, placebo-controlled, randomized, ascending subcutaneous single dose in healthy volunteers followed by multiple dosing in Crohn’s Disease patients. The study will be conducted in the United States.
Glucagon-like Peptide-2 (GLP-2) is a naturally occurring peptide hormone, secreted by the small intestine. GLP-2 binds to and acts exclusively via the GLP-2 receptor, expressed primarily in the gastrointestinal tract. GLP-2 has been shown to have numerous beneficial effects in the small intestine. These include stimulation of the growth of the small intestinal lining, enhancement of nutrient digestion and absorption, and reinforcement of the intestinal barrier function. Moreover, GLP-2 has been shown to decrease inflammation, and to enhance animal survival in a broad range of preclinical models of gut injury including, models of Inflammatory Bowel Disease.
The specific and beneficial actions of GLP-2 in the small intestine makes GLP-2 an attractive therapeutic candidate for the treatment of intestinal injury and/or disease. Nevertheless, GLP-2 is rapidly de-activated in the body (short half-life), representing a significant challenge for the use of GLP-2 clinically. At Zealand Pharma we have applied our knowledge of peptide stabilization and our proprietary SIP® technology to produce a novel GLP-2 agonist, ZP1848. ZP1848 is a biologically stable and potent GLP-2 agonist targeted for the treatment of Crohn’s Disease. We have demonstrated that ZP1848 enhances the regeneration of the intestinal lining leading to increased animal well-being and survival in well-validated models of Inflammatory Bowel Disease (IBD).
ZP1848 is expected to induce and maintain remission by enhancing the regeneration and healing of the small intestinal lining after an inflammatory episode in Crohn’s Disease. This is a novel, innovative and promising therapeutic approach in the treatment of Crohn’s Disease.
ZP1848 has been tested in an extensive preclinical toxicology and safety pharmacology program. In December 2008 an IND was submitted to and approved by the FDA. Zealand Pharma is currently running a Phase I trial to assess the safety and tolerability of ZP1848 in healthy volunteers and Crohn’s Disease patients. Future plans include the testing of ZP1848 in ulcerative colitis.
Dr. David H. Solomon, President and Chief Executive Officer of Zealand Pharma A/S, commented: “Advancing ZP1848 into clinical trials further strengthens our development pipeline. Zealand Pharma has applied its knowledge of peptide optimization and its proprietary SIP® technology to develop a series of novel peptides that specifically enhance the growth and function of the lining of the small intestine. The inadequacies of the current treatment options in Crohn’s Disease coupled with the rise in the incidence of IBD in the industrialized world highlights the need for more efficacious therapeutic approaches for the treatment of IBD. There is a strong need for drugs that are able to act as a Mucosal Regeneration Enhancer and we believe that ZP1848 is a promising drug candidate for the treatment of Inflammatory Bowel Disease”.
Crohn’s Disease
Crohn’s Disease is a chronic, episodic, inflammatory condition of the gastro-intestinal tract characterized by inflammation and transmural lesions (affecting the entire wall of the involved bowel). The other well known IBD is ulcerative colitis which differs from Crohn’s Disease based on the localization of the disease, and its specific pathologies.
The etiology of Crohn’s Disease is unknown but most likely involves immune, genetic, and environmental factors. The most common symptoms of Crohn’s Disease include abdominal pain, cramping, fatigue and diarrhea. Crohn’s Disease can also cause complications outside of the gastrointestinal tract such as skin rashes, arthritis, and inflammation of the eye. The primary goal of treatment in Crohn’s Disease is to suppress and modulate the inflammatory reaction. To achieve this goal antiinflammatory drugs are used. Nevertheless, the use of these therapeutics is associated with significant drawbacks such as serious side effects, frequent dosing and lack of therapeutic efficacy.
Approximately 700,000 people in the leading seven industrialized countries live with Crohn’s Disease in 2006 and the incidence of the disease is on the rise in industrialized societies.
# # #
Further information Mogens Vang Rasmussen, Executive Vice President, Chief Operating Officer and Chief Financial Officer, IT & Communications Zealand Pharma A/S, Smedeland 36, DK-2600 Glostrup, Denmark T +45 4328 1200 F +45 4328 1212 E info@zp.dk www.zealandpharma.com
About Zealand Pharma
Zealand Pharma is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs. Zealand is one of the leaders within the peptide area, a growing market with significant drug development activities including treatment of metabolic and cardiovascular diseases. All of Zealand’s products target diseases and symptoms of significant unmet clinical need and commercial potential.
Since 1999, Zealand’s scientists have built a pipeline that includes five compounds in clinical development, three of which have been out licensed to major pharmaceutical companies (Sanofi-Aventis, Wyeth and Helsinn Healthcare). All Zealand’s compounds emerge from Zealand’s own drug discovery.
* AVE0010/ZP10, a pharmaceutical agent for the treatment of Type 2 Diabetes, has been out-licensed to Sanofi-Aventis, which is the world’s third largest pharmaceutical corporation with a strong diabetes franchise. Phase III clinical trials were initiated in May 2008. * GAP-134/ZP1609; a gap junction modifier that prevents both ventricular and atrial arrhythmias in animal models. With its oral formulation, the molecule represents a novel paradigm for the potential chronic prevention of atrial arrhythmias. US based pharmaceutical giant Wyeth Pharmaceutical is currently conducting Phase I trials in the US. * ZP1846 is an innovative treatment for prevention of chemotherapy-induced diarrhea, which may prevent discontinuation and dose modification during cancer chemotherapy. The compound has been partnered with Helsinn Healthcare SA. * ZP1848 is a novel paradigm for the treatment of Inflammatory Bowel Diseases (e.g. Crohn’s Disease). The compound is in Phase I clinical development.
In addition, Zealand has a rich and broad portfolio of pre-clinical projects targeting a variety of disease areas, including osteoporosis and obesity-related diabetes.
Zealand Pharma A/S is based in Copenhagen and has approximately 65 employees.
The Company’s investors include BankInvest Biomedical Venture, LD Pensions, Dansk Erhvervsinvestering and Sunstone Capital as well as the leading international biotech investors CDC Innovation and AGF Private Equity (both in Paris) and LSP (Amsterdam).
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.
