PRESS RELEASE 29 NOVEMBER 2002

Zealand Pharma announces successful Phase I trials for ZP120 in acute heart failure

Novel ‘Aquaretic’ is first of new class of drugs that selectively increase water excretion without affecting salt levels 

Copenhagen, Denmark, 29 November 2002…Zealand Pharma A/S announces today the successful conclusion of its Phase I clinical trial of ZP120, an ‘aquaretic’ compound designed to treat patients with severe shortness of breath as a result of acute heart failure.

Acute heart failure is the cause of two million hospital admissions each year in the Western world, and shortness of breath (dyspnoea) is a classic symptom of this condition. It results from an accumulation of water in the body, primarily in the pulmonary vessels of the lung. Treatment with traditional diuretics is effective at relieving these symptoms, however, their use also leads to an excessive loss of sodium (Na+) and potassium (K+) salts in the urine, which increases the risk of arrhythmias.

ZP120 is an enhanced peptide, which has been generated by Zealand’s proprietary protein modification technology (SIP-Technology). Its mode of action is via the ORL-1 receptor (ZP120 is an ORL-1 agonist), which is localised to the nephron, the active part of the kidney. This mode of action is very different from all available diuretics.

By its unique ability to selectively increase urinary water excretion, ZP120 represents the first of a new class of drugs called ‘aquaretics’. 

Furthermore, preclinical studies indicate that ZP120 has an additive effect to known diuretics, which is highly relevant for patients, who are already in treatment with these compounds. 

In the double-blind, placebo-controlled Phase I study in 27 healthy volunteers, ZP120 was found to be safe, well-tolerated and effective. Each subject received a single dose of ZP120 (10-1000 ug/kg body weight) or placebo administered subcutaneously. 

Commenting on the results, Eva Steiness, Zealand Pharma’s CEO said, “We are delighted that ZP120 has proved to be safe and effective in this study. At the same time, it shows that our SIP-Technology works in practice. This result is particularly satisfying following so closely the success of another of our clinical products, ZP10, which is in Phase I/IIA trials for Type II diabetes. Both compounds will now progress into further clinical studies and we are currently talking to a number of potential partners about the future development of these products.”

For further information please contact:

Eva Steiness,
President and CEO,
Zealand Pharma
Phone: +45 4328 1210
Email: est@zp.dk

About Zealand Pharma

Zealand Pharma is a biopharmaceutical company located in Copenhagen, Denmark. The company was founded in 1998 to develop its proprietary peptide modification technology, known as SIP Technology (Structure Inducing Probe), which is designed to enhance the stability and potency of new and existing peptide therapeutics.

From this programme, Zealand has advanced two drug candidates from research to clinical development: ZP10 has completed a Phase I/IIA trial within Type II diabetes, and ZP120 has completed a Phase I trial for congestive heart failure.

In order to further strengthen its development portfolio, Zealand Pharma has started to invest in identifying and developing therapeutics that target diseases associated with intercellular communication processes involving gap junctions.

Gap junctions facilitate the transport of small molecules and ions between adjacent cells and form an important part of a coordinated cell signalling process. A wide variety of conditions are associated with altered gap junction communication, including diabetes, cardiovascular disorders, and other degenerative tissue diseases.