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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

GREENWOOD VILLAGE, Colo., Sept. 30, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced additional positive results from the SPRING study (clinicaltrials.gov NCT01839331) of Ampion for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of Ampion achieved a clinically meaningful reduction in pain.  Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints.

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Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "The previously reported achievement of primary end point efficacy for pain (WOMAC A, p=0.0038), function (WOMAC C, p=0.04) and Patient Global Assessment (PGA, p=0.01) at 12 weeks following a single intra-articular injection is now augmented by significant results from secondary end points. The newly announced positive results include:

  • The reduction in pain compared to the vehicle control (saline) was also significant across/over the whole twelve-week period and not just at the 12 weeks end point (p=0.01).
  • This study demonstrated that a single intra-articular (IA) injection of Ampion resulted in a clinically and statistically significant reduction in pain, with an estimated difference from control at the study endpoint of -0.25 on the WOMAC A scale (95% CI: -0.41 to -0.08, p=0.004), corresponding to a 42.3% improvement in pain at 12 weeks in patients treated with Ampion.

Note: In contrast, despite recommendations against their use, Hylan G-F 20 is the current treatment of choice in patients who cannot be managed with ana
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SOURCE Ampio Pharmaceuticals, Inc.
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