Ampio Pharmaceuticals, Inc.,a development stage biopharmaceutical company focused on the rapid development of therapies, has completed 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 four 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 programme 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.”
Ampion is a non-steroidal anti-inflammatory biologic that has the potential to be used in a broad array of inflammatory conditions and autoimmune diseases. The active ingredient is aspartyl-alanyl diketopiperazine, referred to as DA-DKP, which is derived from two amino acids from human albumin and appears to have a significant role in the homeostasis of inflammation. Ampion is protected by composition of matter, use, and synthetic form patents. Ampio has published a number of studies and articles on the anti-inflammatory activity of DA-DKP.
Osteoarthritis (OA) is the most common form of arthritis, caused by inflammation of the soft tissue and bony structures of the joint which worsens over time and leads to progressive thinning of articular cartilage, narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone. These changes eventually result in chronic pain and disability, and deterioration of the joint despite drug therapy may require eventual surgery of total joint replacement. Current drug treatment for OA of the knee relies on pain control with analgesics, and anti-inflammatory treatment with NSAIDs and intra-articular injections of steroids or hyaluronates. The current drug treatments have been shown to have mixed results and may have significant limitations due to various adverse effects such as gastrointestinal irritation and bleeding.