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Ampio Pharmaceuticals, Inc. Announces Additional Positive Results for Ampion(TM) in Osteoarthritis of the Knee Clinical Trial
Date:9/30/2013

lgesics. In the pivotal trial of a single IA injection of 6 ml Hylan G-F 20, a borderline statistically significant reduction in pain was demonstrated, with an estimated difference from control of -0.15 (95% CI: -0.30 to -0.002, p = 0.047), corresponding to a 31.3% improvement in pain over 26 weeks in patients treated with Hylan G-F20.

Note: The accepted threshold for a Minimum Clinically Important Improvement (MCII), defined as the smallest change in a measurement that signifies important improvement in a patient's symptom, is -40.8% [Ann Rheum Dis. 2005;64:29-33 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement] in WOMAC A pain change from baseline with knee OA, which only Ampion exceeded as an intra-articular injection.

  • The Ampion SPRING study included "all comers", including Kellgren-Lawrence IV patients that make up a significant portion of the "real world" osteoarthritis patients (19% in the SPRING study). Ampion was not only effective overall (p=0.004) as previously reported, but was specifically effective in the subset of patients with severe osteoarthritis (Kellgren-Lawrence IV, p=0.017) who currently face a severe unmet medical need.

Note: In contrast pivotal trials for the approved hyaluronic acid and derivatives, which commonly exclude patients with severe osteoarthritis (Kellgren-Lawrence IV stage of disease), these patients are sometimes considered "intractable" due to lack of efficacy of any approved therapy (NSAIDS, hyaluronic acid and steroids). The only accepted therapy is joint replacement, which is not only a significant patient burden but also has significant morbidity associated with it and is contraindicated in many patients with comorbidities.

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SOURCE Ampio Pharmaceuticals, Inc.
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