ARTICLE | Product Development
Adapting for speed
How AM-Pharma's adaptive Phase II trial could speed up development for recAP
January 26, 2015 8:00 AM UTC
The streamlined design of a Phase II study AM-Pharma B.V. started last week, combined with the smaller safety database required, should make up for time spent going back to the drawing board with a recombinant version of its alkaline phosphatase product.
The trial combines the dose-finding components of a Phase IIa and the efficacy components of a Phase IIb trial into a single study. It will enroll 290 patients to evaluate the use of iv recombinant alkaline phosphatase (recAP) to treat sepsis-associated acute kidney injury (AKI). According to CEO Erik van den Berg, the trial will be the largest ever conducted in AKI. The company expects data in 2H16, at which point it will seek a partner. ...