Development-stage biopharmaceutical company Ampio Pharmaceuticals announced it has completed patient enrollment for a dose-escalation run-in study to a Phase III pivotal trial evaluating Ampion for the treatment of moderate to severe osteoarthritis of the knee. It is anticipated that 12-week primary endpoint data will be available in the third quarter of 2013.
Ampion is being evaluated in the SPRING trial for its pain-reducing effect as a single intra-articular injection into the knee in 4 mL and 10 mL volumes, as compared with placebo at 12 weeks. More than the targeted 320 patients have been enrolled in the study, which is part of the U.S. development program for Ampion. The study was designed as a run-in to a Phase III pivotal trial, which the company will initiate as soon as the optimal volume is determined and the proposed pivotal trial is properly powered to meet its scientific objectives.
Ampio set very stringent site criteria to optimize the rate of enrollment in SPRING, and the company is pleased with the speed at which patient enrollment was completed. The company believes this trial can potentially show the inadequacies of current therapeutics in meeting the needs of osteoarthritis sufferers.
Ampion, the product being studied, is a non-steroidal anti-inflammatory biologic with the potential to be utilized in a wide variety of inflammatory conditions and autoimmune diseases. Ampion is protected by composition of matter, use, and synthetic form patents. Active ingredient aspartyl-alanyl diketopiperazine, or DA-DKP, is derived from two amino acids from human albumin and appears to have a significant role in the homeostasis of inflammation. The company has published various studies and articles about the anti-inflammatory activity of DA-DKP.
For more information, visit www.ampiopharma.com
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