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Ampio Gets Pivotal OAK Confirmation

FDA accepts study as pivotal for osteoarthritis BLA

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ampio Pharmaceuticals has received correspondence from the FDA confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion for the treatment of osteoarthritis of the knee (OAK).

The FDA’s letter summarized the FDA’s conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting. According to the company, the letter noted that study AP-003-A can be considered as one of two ‘pivotal trials’ required in support of a BLA, a recommendation based on the fact that the study was adequate and well controlled, the trial conduct was acceptable and the study met its primary endpoint of a change in WOMAC score at 12 weeks. The FDA also noted that a study to evaluate safety and efficacy of repeat dosing may be conducted after market approval.

The final pivotal trial will confirm the efficacy and safety of the 4 ml injection in approximately 500 patients with a follow-up of no less than 20 weeks in order to better understand the duration of action. This trial is planned to begin in early January 2014 with an additional six clinical sites added to the nine sites utilized in the SPRING study. Submission of the BLA could occur as soon as 3Q14.

The company has accelerated the building of a manufacturing facility in Colorado that will produce commercial amounts of Ampion to satisfy demand for this and future indications. The company plans to initiate new studies for the treatment of such diseases as COPD and Crohn’s disease.

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