Intra-Articular Treatment (Ampion) Shows Promise in Early OA Trial
Endogenous immunomodulatory molecule reduces inflammation
Promising results have been reported from a small (N = 7) study of multiple injections of Ampion (aspartyl-alanyl diketopiperazine [DA-DKP]) into the knees of patients with osteoarthritis (OA).
In the first part of an open-label, multiple-injection trial, the patients received three 4-mL intra-articular injections of Ampion (at baseline, 2 weeks, and 4 weeks). In order to proceed with a planned randomized, vehicle-controlled portion of the study, the open-label findings must demonstrate the safety and efficacy of three injections of Ampion compared with the single injection evaluated in a previous study (the SPRING trial). No drug-related serious adverse events occurred during the first 6 weeks of the current trial.
The mean WOMAC A pain score improved by 86% in the multiple-injection study (from 2.2 at baseline to 0.3 at week 6; P < 0.001) compared with an improvement of approximately 40% in the single-injection SPRING study at the same time point. In addition, the mean WOMAC C function score improved by 87% (from 2.3 at baseline to 0.3 at week 6; P = 0.0003) in the multiple-injection trial.
According to the product’s developer (Ampion Pharmaceuticals), all of the patients reported almost complete resolution of pain and major improvements in function at week 6. Baseline magnetic resonance imaging and synovial fluid analysis, performed in each patient just before the start of the multiple injections, will be repeated at week 12 and will be compared with baseline findings to determine whether there are additional clinical benefits beyond pain relief and improved function.
Ampion is a low-molecular-weight fraction of human serum albumin (HSA) currently being developed for the treatment of knee OA. Additional preclinical and clinical studies of Ampion have been completed or are under way in patients with Crohn’s disease, chronic obstructive pulmonary disease, and other chronic inflammatory conditions.
The primary ingredient of Ampion is DA-DKP, an endogenous immunomodulatory molecule derived from the N-terminus of HSA. Based on pre-clinical and clinical research, DA-DKP plays a key role in the regulation of inflammation. DA-DKP is believed to reduce inflammation by suppressing the production of pro-inflammatory cytokines in T-cells. Ampion also contains other small molecules that confer anti-inflammatory effects to complement the activity of DA-DKP.