Skip to main content
BioCentury on BioBusiness
Feature Story

Adapting for speed

How AM-Pharma's adaptive Phase II trial could speed up development for recAP

By Stephen Hansen, Associate Editor

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.

Read Article

Today's Biotech & Pharma News

  • THE DISTILLERY brings you this week's most essential scientific findings in therapeutics, distilled by Innovations editors from a weekly review of more than 400 papers in 41 of the highest-impact journals in the fields of biotechnology, the life sciences and chemistry. The Distillery goes beyond the abstracts to explain the commercial relevance of featured research, including licensing status and companies working in the field, where applicable.

    This week in therapeutics includes important research findings on targets and compounds, grouped first by disease class and then alphabetically by indication.

    This week in techniques includes findings about research tools, disease models and manufacturing processes that have the potential to enable or improve all stages of drug discovery and development.

Subscribe Now
Free Trial