Ampion: Phase I data

Data from 7 patients with OA of the knee in the open-label Phase I portion of the 2-part, U.S. Phase I/II MULTIPLE INJECTIONS STUDY showed that 3 injections of 4 mL Ampion given 2 weeks apart led to no treatment-related serious adverse events. Additionally, Ampion significantly reduced mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) pain subscale score at week 6 by 1.9 points compared to baseline (p=0.001) and significantly reduced mean WOMAC-C function subscale score at week 6 by 2 points compared to baseline (p=0.0003). Ampio is now enrolling 30 patients in the double-blind Phase II portion of the trial to compare Ampion vs. saline.

Ampion is also in the Phase III STEP and SPRING trials in the indication. Last year, Ampio reported data from SPRING showing that Ampion met the primary endpoint of reducing pain as measured by WOMAC-A scores from baseline to week 12 vs. saline vehicle control (p=0.0038) (see BioCentury, Aug. 19, 2013 & Oct. 7, 2013). In August, Ampio disclosed that an independent CRO discovered that Ampion and placebo were exposed to "lower temperatures than permitted by the drug specifications" during shipment to trial sites in the STEP trial (see BioCentury, Sept. 1). ...