GREENWOOD VILLAGE, Colo., Aug. 14, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced positive results from the SPRING study (clinicaltrials.gov NCT01839331) of Ampion for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of Ampion achieved a clinically meaningful reduction in pain.
The SPRING study, was a randomized (1:1:1:1), double-blind, vehicle controlled trial designed to evaluate the safety and efficacy of Ampion in OAK patients. Patients were randomized to receive one of two doses (4 mL or 10 mL) of Ampion or corresponding saline control via intra-articular injection. The primary study objective was to evaluate the relative efficacy of Ampion 4 mL versus Ampion 10 mL. The primary endpoint was mean change in pain from baseline for Ampion compared to the same volume of saline. Secondary endpoints included evaluating safety and quality of life, as well as, stiffness and function.
Ampion dose cohorts experienced statistically significant reductions in pain compared to control. There were no significant differences between the efficacy of the two Ampion doses. Selection of the optimal dose for the second Phase 3 trial will be decided in consultation with the U.S. Food and Drug Administration (FDA).Michael Macaluso, Chairman and Chief Executive Officer, said, "We are very pleased with the results of the trial. Both doses of Ampion provided osteoarthritis patients with pain relief. The broad inclusion criteria for the trial reflected a real world application of this biologic to a diverse patient population, making these results even more impressive. This should greatly encourage the enormous population of patients afflicted with OAK and the physicians who treat them." A brief summary of the combined Ampion topline results are as follows:
- Patients receiving Ampion achieved significantly greater reduction in pain (WOMAC A) from baseline to 12 weeks compared to saline vehicle control (p = 0.0038).
- Patients receiving Ampion experienced, on average, a greater than 40% reduction in pain from baseline.
- Patients receiving Ampion also achieved significantly greater improvement in function (WOMAC C) from baseline to 12 weeks compared to saline vehicle control (p = 0.044).
- Patients receiving Ampion also demonstrated significantly greater improvement in overall quality of life measures (Patient Global Assessment) from baseline to 12 weeks compared to saline vehicle control (p = 0.012).
- Clinical efficacy defined as pain reduction was evident as early as four weeks after the injection (p = 0.025) and continued to show improvement through 12 weeks (p = 0.0038).
- Ampion was well tolerated with minimal adverse events (AEs) reported in the study. AEs were well balanced between Ampion and control groups. There were no drug-related serious adverse events (SAEs).