Action Pharma completes dosing in phase II clinical trial with AP214 to prevent acute kidney injury

30-Mar-2010 - Denmark

Action Pharma A/S has completed dosing in the second phase II clinical trial with its leading development candidate, AP214. Interim efficacy data are expected June 2010. AP214 is being developed for protection of acute kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication.

“Completing the dosing ahead of schedule in the phase II clinical trial is a major milestone for Action Pharma”, says Ingelise Saunders, CEO of Action Pharma. She continues, “it also represents an important step forward in our partnering and corporate development strategy.”

The clinical trial is a randomized, double-blind, placebo-controlled, dose-finding, phase II trial in 42 patients undergoing cardiac surgery under cardiopulmonary bypass. Key unblinded results are expected in June 2010 while full unblinded data are foreseen in Q3 2010.

“Many patients in the USA and Europe each year undergo major thoracic surgery, and approximately 10-20% of these patients experience various degrees of kidney injury which again are associated with increased mortality, co-morbidity and prolonged hospitalization. Currently, no treatment is available. Thus, this indication addresses a major unmet medical need, and we expect the commercial potential to be approximately EUR 500 million with expansion potential in additional indications”, says Søren Nielsen, COO of Action Pharma.

The clinical trial has been conducted in Denmark at the Department of Cardiac and Thoracic Surgery at Rigshospitalet (the Danish State Hospital) in Copenhagen, and at Odense University Hospital in Odense, respectively.

AP214 is a new first-in-class drug candidate with a novel mode of action. It mediates its action through new pharmacological targets, the melanocortin receptors. AP214 is expected to reduce the inflammatory response as well as post-surgical reperfusion injuries, factors known to cause kidney injury. Initial results from an earlier phase II clinical trial in the USA and from a phase IB clinical trial in human volunteers subjected to LPS-induced inflammation, revealed positive effects of AP214.

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