Biopharmaceutical company Ampio Pharmaceuticals has completed patient enrolment in its run-in SPRING study of Ampion to treat osteoarthritis of the knee.
The trial will assess the efficacy of Ampion in reducing pain as a single intra-articular injection to the knee in 4ml and 10m doses, as compared to placebo at twelve weeks.
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The study, part of the US development programme for Ampion, has exceeded its target of enrolling 320 patients.
Ampio chairman and CEO Michael Macaluso said; "While we set very stringent site criteria to optimise the rate of enrollment, I believe this could indicate the severe degree current therapeutics are not meeting the needs of osteoarthritis sufferers."
The company expects to announce its twelve-week primary endpoint data in the third quarter of 2013.
The study was designed as a run-in to a Phase III trial, which will be commenced by the company upon the determination of the optimal dose.
Ampion is a non-steroidal anti-inflammatory biologic with the potential to be used in a range of inflammatory conditions and autoimmune diseases.
