Last patient completes last visit in Action Pharma’s phase IIb clinical trial with AP214 to prevent kidney injury associated with major cardiac surgery
The final patient has performed the last visit of the study period in Action Pharma’s US and Denmark based phase IIb study. Treatment with AP214 is designed to investigate whether acute kidney injury can be prevented in patients undergoing major cardiac surgery – a serious unmet medical need with no treatment currently available on the market. Top line results from the study are expected to be reported as planned, in September 2011.
The last patient in the US and Denmark based AP214 phase IIb clinical study has now completed the 3-month visit leading to the closure of the study period in the trial. This important achievement in the AP214 phase IIb program will be followed by data compilation from the 8 clinical sites in the US and Denmark, and from the central laboratory. The top line results are expected to be reported as planned, in September 2011. Following good results from the study, Action Pharma A/S will enter into partner discussions.
"This is a critical period for Action Pharma, for the investigating physicians, and for all the patients, who have chosen to participate in the clinical study. The clinical study is also of major importance for the entire field of cardiovascular and organ protection", says Ingelise Saunders, CEO of Action Pharma. She continues, “we estimate that the potential market for global renal protection in cardiac surgery exceeds EUR 500 million with considerable expansion potential in follow-on indications. With AP214, we have the opportunity to be first to market”.
The clinical phase IIb trial has been conducted at 3 sites in Denmark and 5 sites in the US studying a total of 77 patients. The trial is a randomized, double-blind, placebo-controlled trial with two dose levels of AP214 administered during surgery and early in the postoperative period. The trial focused on evaluating the efficacy, safety and tolerability of AP214 in preventing acute kidney injury and systemic inflammatory response commonly seen in patients undergoing cardiac surgery on cardiopulmonary bypass and with increased risk of developing kidney injury.
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