A small and open-label study of Ampio Pharmaceuticals’ (AMPE) AMPION given in multiple injections demonstrated positive results at 6-weeks, said Ampio on Monday morning, producing pain reduction in patients with opsteoarthritis of the knee and no new safety signals. The data come on the heels of 4-week results in early August, and the company expects to file for FDA approval in the first quarter of 2015 (slipped from “late 2014”). The prior SPRING study tested Ampion as a one-time injection in osteoarthritis, and a second pivotal trial (STEP) should be complete shortly. Ampio hopes the new open-label trial will allow for label expansion to include multiple doses.
AMPE climbed 7% in pre-market trading.
Patients received three 4ml injections of Ampion, at baseline, week 2, and week 4. According to AMPE, average pain (WOMAC A) improved by 86% from baseline to 6 weeks (2.2 to 0.3, p=0.001), and a score of function (WOMAC C) improved by 87% from baseline to week 6 (2.3 to 0.3, p=0.0003). On the pain score, Ampio says this compares to a 40% reduction in the SPRING study, following a single injection. It’s important to note that patients are NOT blinded in this study, nor are results compared to a placebo control.
Ampio initiated the new open-label study this June in patients with severe osteoarthritis of the knee for which there is no current non-surgical therapy, with a goal of enrolling 37 patients. The first portion of the study (n=7) is designed to measure safety, though the company has twice reported efficacy outcomes since July. The second phase (n=37( will evaluate efficacy and cartilage formation vs. saline.
Ampion is aspartyl-alanyl diketopiperazine (DA-DKP), a biologic derived from the N-terminus of human serum albumin.
