Action Pharma obtains positive results in a phase II clinical trial with AP214

15-Sep-2010 - Denmark

Action Pharma A/S has obtained positive safety, tolerability and efficacy results in the second phase II clinical trial (CS005) with its leading development candidate, AP214. AP214 is being developed for protection of acute kidney injury (AKI) in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication.

The clinical phase II trial is a randomized, double-blind, placebo-controlled sequential dosefinding trial with three dose levels, and safety and tolerability as primary objectives. 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 results demonstrate that AP214 is well tolerated and safe at all three dose levels. At the highest dose level, AP214 markedly reduced the development of AKI by 70%, and reduced the IL-6 response by 40%, compared to placebo. This is consistent with a robust effect to prevent postsurgical acute kidney injury and systemic inflammatory response associated with major cardiac surgery.

“The very encouraging key results in the CS005 phase II clinical trial with AP214 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 process related to the project.”

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