Holte, Denmark, June 7, 2010 -- Action Pharma A/S obtained encouraging preliminary blinded results in the second phase II clinical trial (named CS005) with its lead development candidate, AP214.
AP214 is being developed for protection of acute kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication.
The phase II clinical trial is a randomized, double-blinded, placebo-controlled, sequential, dose-finding trial with three dose levels in 42 patients. Primary objectives are safety and tolerability. Secondary objectives include effects on kidney function/injury and on the systemic inflammatory response by determinations of changes in serum creatinine and plasma IL-6. The preliminary results are blinded without the results from statistical analyses.
The results demonstrate that AP214 is well tolerated and safe at all three dose levels. At the highest dose level, AP214 prevents the increase in serum creatinine by 50-60%, and in the IL-6 response by 30-40%, compared to placebo (trends based on blinded data). This is consistent with a robust effect to prevent postsurgical acute kidney injury (AKI) and systemic inflammatory response.
“The encouraging preliminary results of treatment with AP214 in the CS005 phase II clinical trial is a major milestone for Action Pharma”, says Ingelise Saunders, CEO of Action Pharma. She continues, “this also represents an important step forward in our partnering and corporate development strategy prior to the forthcoming final, unblinded data expected in September."
“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 is associated with increased mortality, co-morbidity and prolonged hospitalization. Currently, there is no treatment available”, says Søren Nielsen, COO of Action Pharma. He continues, “consequently, this indication addresses a major unmet medical need, and we estimate the commercial potential to be approximately EUR 500 million with expansion potential in additional indications”.
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.
