Clinical Trials

Date: 2011-09-26

Type of information: Initiation of preclinical development

phase: 2b

Announcement: results

Company: Action Pharma (Denmark)

Product: AP214

Action mechanism:

AP214 is an analogue of α melanocyte-stimulating hormone that targets both systemic inflammation and apoptosis caused by hypoxia that can occur during surgery.

Disease:

renal protection in cardiac surgery

Therapeutic area: Cardiovascular diseases - Renal diseases - Kidney diseases

Country: Denmark, USA

Trial details:

The clinical phase IIb trial is randomized, multi-center, double-blind, placebo-controlled with two dose levels of AP214 administered during surgery and early in the postoperative period. The trial studied 77 patients undergoing cardiac surgery across 8 sites, 3 in Denmark and 5 in the US (study conducted by CTI Clinical Trial and Consulting Services, Cincinnati, Ohio, the USA, as clinical CRO).

Latest news:

Action Pharma has announced positive top-line results for its phase IIb AP214 trial in patients undergoing major cardiac surgery. The study demonstrated that AP214 is safe, reduces kidney injury, and improves long-term (90 days) outcomes on a composite end point (death, dialyses and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury. In addition, this study validates and expands on previous positive AP214 safety and efficacy data from a phase IIa trial.
A top-line efficacy analysis indicates that AP214 resulted in:
- Statistically significant improvement in clinical outcomes based on a 90 day composite endpoint (death, dialyses, and kidney function) compared to placebo – a possible endpoint for registration trials based on the Company’s previous discussions with the FDA
- Statistically significant improvement in GFR (glomerular filtration rate) at day 90 compared to baseline
- Lower incidence of acute kidney injury (AKI) within 48 hours (AKIN score) or 7 days (RIFLE score)
- Lower serum creatinine levels at day 7

AP214 was safe and well-tolerated comparable to placebo. The clinical results are expected to be presented as late breaking clinical abstract at the annual meeting of the ASN (American Society of Nephrology) to be held on November 8-13 in Philadelphia, PA, USA.

Is general: Yes