Ampio announced positive results from the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK). Ampion, also known as aspartyl-alanyl diketopiperazine or DA-DKP, is an endogenous immunomodulatory molecule derived from the N-terminus of human serum albumin (HSA) that may have a significant role in the homeostasis of inflammation.
The SPRING study, was a randomized (1:1:1:1), double-blind, vehicle controlled trial in 329 patients designed to evaluate the safety and efficacy of Ampion in OAK patients. Patients were randomized to receive one of two doses (4mL or 10mL) of Ampion or corresponding saline control via intra-articular injection. The primary study objective was to evaluate the relative efficacy of Ampion 4mL vs. Ampion 10mL. The primary endpoint was mean change in pain from baseline for Ampion compared to the same volume of saline.
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).
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