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Ampio Pharmaceuticals, Inc. Announces Positive Results for Ampion in Osteoarthritis of the Knee Clinical Trial
Date:8/14/2013

ith OAK and the physicians who treat them."

A brief summary of the combined Ampion topline results are as follows:

  • Patients receiving Ampion achieved significantly greater reduction in pain (WOMAC A) from baseline to 12 weeks compared to saline vehicle control (p = 0.0038).
  • Patients receiving Ampion experienced, on average, a greater than 40% reduction in pain from baseline.
  • Patients receiving Ampion also achieved significantly greater improvement in function (WOMAC C) from baseline to 12 weeks compared to saline vehicle control (p = 0.044).
  • Patients receiving Ampion also demonstrated significantly greater improvement in overall quality of life measures (Patient Global Assessment) from baseline to 12 weeks compared to saline vehicle control (p = 0.012).
  • Clinical efficacy defined as pain reduction was evident as early as four weeks after the injection (p = 0.025) and continued to show improvement through 12 weeks (p = 0.0038).
  • Ampion was well tolerated with minimal adverse events (AEs) reported in the study. AEs were well balanced between Ampion and control groups. There were no drug-related serious adverse events (SAEs).

"This [result] is fantastic," stated Dr. Brian McGrath, principal investigator and orthopedic surgeon at University Orthopedics Services in Amherst, New York. "These results highlight the strong possibility that it may soon be possible to offer patients an effective [injectable] therapy."

Dr. Nathan Wei, rheumatologist at Arthritis Treatment Center in Frederick, Maryland, said, "I was pleasantly surprised at the positive response rate in patients with otherwise intractable osteoarthritis of the knee. I am also hoping to study Ampion injections into the base of the thumb and base of the toe for which there i
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SOURCE Ampio Pharmaceuticals, Inc.
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