Ampio Pharma (AMPE) Reports Statistically Significant Data from Ampion in the Knee Analysis

Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), announced the completion of the planned analysis of the day 84 data of the Ampion in the Knee (AIK) study conducted in Australia. With the previously reported positive results 30 days after a single injection to the knees of patients suffering from osteoarthritis, the analysis was extended to also review pain outcomes at day 84 after the injection.

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained:

• "There are a number of ways to analyze the pain score data to determine efficacy. One method is to determine if any change from baseline is significant (each patient serves as their own control). The change from baseline for the Ampion treated patients was statistically significant at both 30 and 84 days after injection (p < 0.05 for day 30 and day 84) and the change from baseline for the placebo treated patients was not statistically significant (p =0.08 day 30, p= 0.34 at day 84).
  
  
• "The difference in pain relief between Ampion™ and placebo at day 84 after a single injection into the knee was statistically significant (p=0.04, n=32) despite the small number of patients included in each group (saline and Ampion™ groups).
  
  
• "Another relevant way to assess pain relief is the "responders vs. non- responders" to treatments at day 84. A "responder" was defined as someone who experienced a two or more points shift improvement in pain relief as measured by the numerical pain scale (scale of 1-10). Non-responders experienced an improvement of at most 1 point or an actual worsening of pain relief. Percentage of "responders" in the group who received Ampion™ was more than twice the percentage of those who received saline (53% vs. 24%) and this approached statistical significance (p=0.06)."

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