AKLRD has successfully completed a Phase I APPA in Osteoarthritis (OA) trial. The Principal Investigator of this study summarized in the results that the primary endpoint had been met as “APPA was demonstrated to be safe and well-tolerated by all subjects in the trial”. The full study report will be available shortly.
The National Institute for Health Research (NIHR) support approved Phase 1 study, sponsored by University of Liverpool, was primarily designed to assess safety. A successful Phase 1 study is a major milestone in the development of any drug candidate. Complete results will be submitted for future publication.
The Phase 2 trial has been authorised by the Danish regulator and recruitment is underway with completion expected Q3 2021. The 150 patient OA Phase II study will assess efficacy in pain and function improvement, along with an assessment of disease modification by validated biomarkers.