Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) today announced the completion of patient enrollment in a dose-escalation run-in study to a Phase III pivotal trial evaluating Ampion in the treatment of moderate to severe osteoarthritis of the knee. Twelve week primary endpoint data are expected in the third quarter of 2013.
In the SPRING trial, Ampion is being evaluated for its effect on reducing pain as a single intra-articular injection into the knee in 4 milliliter (mL) and 10 milliliter (mL) volumes as compared to placebo at twelve weeks. The study has enrolled in excess of the targeted 320 patient goal. This study is part of the US development program for Ampion and was designed as a run-in to a Phase III pivotal trial which Ampio will initiate once the optimal volume is determined and the proposed pivotal trial is properly powered to achieve its scientific objectives.
"I am extremely pleased with the speed we were able to complete patient enrollment in SPRING," said Michael Macaluso , Chairman and CEO of Ampio. "While we set very stringent site criteria to optimize the rate of enrollment, I believe this could indicate the severe degree current therapeutics are not meeting the needs of osteoarthritis sufferers."
Ampio Pharmaceuticals, Inc.