Action Pharma initiates phase IIb clinical trial with AP214 to prevent kidney injury associated with major cardiac surgery
Action Pharma A/S has administered the first dose to the first patient in a phase IIb clinical trial being undertaken in the USA and Denmark with its leading drug candidate AP214. This follows the positive results obtained on safety, tolerability and efficacy in the phase IIa clinical trial announced in September 2010.
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 dosing of the first patient 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. The objectives are efficacy of AP214 in preventing kidney injury and systemic inflammatory response, and on safety and tolerability. 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.
“Many patients in the USA and the EU each year undergo major cardiac 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”, says Søren Nielsen, COO of Action Pharma. He added, “with no treatment currently available, this indication addresses a major unmet medical need which is recognized by key opinion leaders and regulatory authorities. The phase IIb clinical trial and the development program are based on positive discussions with FDA.”
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