Updated results in study of Ampion for Osteoarthritis:Knee -Ampio Pharma

Ampio Pharmaceuticals has announced updates for the STRUT and STRIDE multiple injection studies with Ampion (aspartyl-alanyl diketopiperazine), for patients with Osteoarthritis of the Knee, that are proceeding simultaneously. The seven patient phase of the 47 patient STRUT study was performed to assure that multiple injections of Ampion were safe. Each patient received three 4ml intra-articular injections of Ampion, one at baseline, the second at 2 weeks and the third at four weeks. In addition, every patient received a high resolution MRI prior to the first injection and eight weeks after the last injection. There were no drug related serious adverse events reported during the first 12 weeks of this current trial.

Results are: WOMAC A: This primary endpoint pain score for the 7 patients improved by 95% from baseline at 12 weeks. (WOMAC A mean (SD) improved from 2.27(0.59) at baseline to 0.11(0.23) at week 12. In comparison, the WOMAC A pain score for the SPRING study improved by 42% at the same time point. WOMAC B: This secondary endpoint measurement of stiffness, also improved significantly by 89% from baseline at week 12. In comparison the WOMAC B score in the SPRING study showed no improvement over baseline at the same time point. WOMAC C: This secondary endpoint of a validated measure of simple daily physical functions improved by 92% from baseline at week 12 (WOMAC C mean improved from 2.37(0.55) to 0.19(0.23). In comparison, the WOMAC C score in the Spring Study improved by 22 % at the same time point. PATIENT'S GLOBAL ASSESSMENT of DISEASE Severity: As measured by the 5 point Likert score, this secondary endpoint improved significantly by 59% from baseline at week 12.