Anti-Inflammatory Drug Ampion Shows Promise in Knee OA
Biologic agent meets all primary and secondary endpoints in phase 3 trial (August 14)
Positive results have been announced from the phase 3 SPRING trial of Ampion (Ampio Pharmaceuticals), an endogenous immunomodulatory molecule, for the treatment of osteoarthritis (OA) of the knee. In this study, 329 patients treated with a single intra-articular injection of Ampion achieved a clinically meaningful reduction in pain.
The SPRING trial was a randomized, double-blind, vehicle-controlled study designed to evaluate the safety and efficacy of Ampion in patients with knee OA. The patients were randomly assigned to receive one of two doses (4 mL or 10 mL) of Ampion or corresponding saline control via intra-articular injection. The study’s primary endpoint was the mean change in pain from baseline for Ampion compared with the same volume of saline. Secondary endpoints included evaluating safety and quality of life (QOL), as well as stiffness and function.
Key results include:
- Patients receiving Ampion achieved significantly greater reduction in pain (WOMAC A) from baseline to 12 weeks compared with 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 with saline vehicle control (P = 0.044).
- Patients receiving Ampion also demonstrated significantly greater improvement in overall QOL measures (Patient Global Assessment) from baseline to 12 weeks compared with saline vehicle control (P = 0.012).
- Clinical efficacy, defined as pain reduction, was evident as early as 4 weeks after the injection (P = 0.025) and continued to show improvement through 12 weeks (P = 0.0038).
Ampion, also known as aspartyl-alanyl diketopiperazine (DA-DKP), is an endogenous immunomodulatory molecule derived from the N-terminus of human serum albumin. According to the drug’s developer (Ampion Pharmaceuticals), the DA-DKP molecule appears to have a significant role in the homeostasis of inflammation. DA-DKP is believed to reduce inflammation by suppressing pro-inflammatory cytokine production in T-cells. The nonsteroidal, low-molecular-weight, anti-inflammatory biologic agent is currently being developing as an intra-articular injection for the treatment of knee OA.
Source: Ampio Pharmaceuticals; August 14, 2013.