Completion of Phase 2a Human Trial

AKL Research and Development (AKLRD) has recently completed 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. It advances our ability to select the patients most likely to benefit from APPA. Key Findings from the trial:

  • Whilst APPA was not overall associated with significantly improved outcomes compared to placebo in the total trial population, APPA did demonstrate significantly (p=0.02) greater pain relief than placebo in a predefined subgroup of patients with more severe disease
  • Further post hoc analyses showed patients with bilateral OA and higher baseline pain scores had significantly more pain relief than placebo
  • APPA was well tolerated

All of the data generated to date warrants a longer trial duration with multiple doses, in the trial population of more severe OA. This is the largest patient group and the group with the highest unmet need