Ampion: Phase III data

Ampio said that data from the double-blind, placebo-controlled, U.S. Phase III STEP trial evaluating a single 4 mL intra-articular injection of Ampion confirmed that 382 (72%) of the 475 patients with OA of the knee in the per protocol (PP) population received study medication that had "fallen below the product specification temperature range." The company said the temperature deviation affected its ability to perform the statistical analysis according to plan and likely affected the level of active ingredients in Ampion. In August, Ampio disclosed that an independent CRO discovered the temperature deviations (see BioCentury, Sept. 1).

In patients with the most severe form of OA of the knee (n=185), defined as Kellgren-Lawrence (KL) grade IV, Ampion (inclusive of temperature excursions) non-significantly reduced WOMAC-A pain subscale scores, the primary endpoint, from baseline to week 20 vs. placebo (0.86 points vs. an increase of 0.66 points, p=0.08). In KL grade IV patients, Ampion also non-significantly reduced WOMAC-C function subscale scores from baseline to week 20 vs. placebo (0.84 vs. 0.64 points, p=0.07). In KL grade IV patients who received study medication outside of the recommended range (n=134), Ampion significantly reduced WOMAC-A pain subscale scores (0.85 vs. 0.58 points, p=0.04) and WOMAC-C function subscale scores (0.87 vs. 0.59 points, p=0.03) vs. placebo. The most common adverse event reported was arthralgia and no serious adverse events related to Ampion were reported. ...