BioWorld International Correspondent

Danish biopharmaceutical firm Zealand Pharmaceut-icals A/S moved into clinical development its second compound, a candidate treatment for patients with acutely decompensated heart failure who suffer from excessive fluid retention.

The drug candidate, a modified peptide called ZP120, has what the company called “an aquaretic effect”: it promotes fluid loss, but without the accompanying loss of electrolytes associated with commonly used diuretics. The Glostrup-based company has observed this effect in animal models. The current trial is a Phase I study in healthy volunteers, but it also will provide the company with some data on the aquaretic effect in humans. The study is being conducted at a U.S. center.

Acutely decompensated heart failure (ADHF), Zealand said, leads to more than 1 million hospital admissions in the U.S. every year. The condition can be triggered by influenza infection and other stresses, said Jakob Dynnes Hansen, chief financial officer and vice president of finance and licensing at Zealand. Dosing commenced at the beginning of the month and should be completed this quarter, he said. The company said it would like to proceed to a Phase II trial by the year’s end, by which time it also expects to commence partnering discussions.

Zealand has one other drug candidate in clinical development, a Type II diabetes treatment, ZP10, which is the subject of a joint venture with Elan Corp. plc, of Dublin, Ireland. ZP10, which is in Phase I/II trials, is an analogue of Glucagon-like peptide-1 (GLP-1). Unlike ZP120, it has undergone modification via Zealand’s proprietary Structure Inducing Probe technology, which enhances the stability and half-life of certain peptide molecules. Dosing is due to be completed in one month, Dynnes Hansen said, and “the data will be reported probably in the beginning of the third quarter.”

Zealand’s third compound, a candidate arrhythmia drug called ZP123, is still in preclinical development. This is the first molecule the company has discovered using an approach based on gap junction modulation.

Zealand, which was formed in 1998, has raised DKK200 million through two private equity rounds, its joint venture with Elan and a soft loan from the state-backed fund VaekstFonden. It hopes to close EUR12 million to EUR15 million in third-round funding this quarter, Dynnes Hansen said. Interest in the company is high, he said, but the international investment funds are moving slowly.

“They have become very cautious. They put a lot of resources into due diligence. I think the processes are a lot more lengthy than in the past,” he said.