Phase 2a Human Trial Key Findings

AKL has completed analysis of a Phase 2a, 28-day 150 patient, trial of oral APPA in osteoarthritis (OA) of the knee.

The data from this Phase 2a trial adds considerably to our understanding of APPA. The trial was designed to assess the efficacy of APPA in subjects with varying degrees of osteoarthritis and, in predefined subgroups, to identify those who would benefit the most.

It advances our ability to select the patients most likely to benefit from APPA. Key findings from the trial:

  • APPA demonstrated significantly (p=0.02) greater pain relief than placebo in a predefined subgroup of patients with more severe disease
  • Subgroup is now the focus of further clinical development
  • Additional post hoc analyses also showed APPA treated patients with OA in both knees and with greater baseline pain scores had significantly more pain relief than placebo

The data generated warrants a longer trial duration with multiple doses in a trial population of more severe OA, this also being the target commercial population.

A copy of an abstract published on the Phase 2a trial can be found here.