Ampion: Additional Phase I data

Additional 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 STRUT trial showed that 3 injections of 4 mL Ampion given 2 weeks apart significantly improved mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) pain subscale score to 0.11 points at week 12 from 2.27 points at baseline (p=0.0001 compared to baseline). Additionally, Ampion led to significant improvements at week 12 compared to baseline in mean WOMAC-B stiffness subscale score (0.29 vs. 2.75 points, p=0.0002), mean WOMAC-C function subscale score (0.19 vs. 2.37 points, p=0.0002) and Patient Global Assessment (PGA) score (1.43 vs. 3.5 points, p=0.003). No serious adverse events were reported. Ampio has completed enrollment of 40 additional patients in the double-blind, placebo-controlled Phase II portion of the trial. The company reported 6-week data from the trial in August (see BioCentury, Sept. 29). ...