Action Pharma completes dosing in phase IIb clinical trial with AP214 to prevent acute kidney injury associated with cardiac surgery

10-May-2011 - Denmark

Action Pharma A/S has completed dosing in a phase IIb clinical trial with its leading development candidate, AP214. Efficacy and safety data are expected during the third quarter of 2011.

AP214 is being developed for protection of kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication – an indication with a major unmet medical need and with no treatment available on the market.

“The completion of dosing in this phase IIb clinical study is a major milestone for Action Pharma and represents an important step forward in our partnering process related to this project”, says Ingelise Saunders, CEO of Action Pharma. She continues, “the area of acute kidney injury is very interesting and we expect the global commercial potential to exceed EUR 500 million with considerable expansion potential in additional indications. With AP214, we have the opportunity to be first to market.”

The clinical phase IIb trial is a randomized, double-blind, placebo-controlled trial with two dose levels of AP214. A total of 78 patients were recruited in the phase IIb study at sites in Denmark and in the USA. The objectives of the study include measuring the efficacy of AP214 in preventing kidney injury and systemic inflammatory response, and on safety and tolerability levels. The trial is focused on patients undergoing cardiac surgery on cardiopulmonary bypass and with increased risk of developing kidney injury. The protocol has been designed following detailed discussions with the FDA on the AP214 clinical development program.

https://www.bionity.com/en/news/132328/action-pharma-completes-dosing-in-phase-iib-clinical-trial-with-ap214-to-prevent-acute-kidney-injury-associated-with-cardiac-surgery.html