Action Pharma obtains encouraging preliminary results in a phase II clinical trial with AP214
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.”
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