AKL > Research & Development > APPA [AKL4] > APPA Data

A clean safety profile and a growing body of human and animal data aligns with the increasing insight of how the MoA links to patients' pathology

In animal testing APPA has demonstrated repeated and significant pain relief from OA, improved functionality and slowing of cartilage destruction, something which no approved drug has demonstrated

3 Canine Trials

Client owned dogs diagnosed with established naturally occurring OA

  • Study 1, in 32 canine patients, significant pain relief
  • Study 2, in 60 canine patients, significant benefits over Meloxicam
  • Study 3 significant disease modification in the key measure

3 Rat Meniscal Tear Studies

  • Gold standard model
  • Significant disease modification
  • Significant pain relief

Anecdotal Experience in Refractory Human Subjects

  • No reported adverse events
  • Reduced pain
  • Patient reported improvement in QoL

Human Phase 1 and Phase 2 Clinical Trials

  • In both trials, APPA was well tolerated and no significant safety signals were noted
  • The APPA phase 2a 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
  • The Phase 2a trial successfully identified subjects with more severe disease benefited with a statistically significant improvement in pain vs placebo although the primary endpoint (WOMAC pain score) for all patients was not achieved
  • Further post hoc Phase 2a analyses showed patients with greater pain and with OA in both knees also benefitted from a significant improvement with APPA vs placebo
  • The Phase 2a results supports further investigation of APPA as a potential OA treatment for patient populations with more severe OA. This is the largest patient group and the group with the highest unmet need

IP

  • APPA is covered by granted patent in 37 major markets (including USA, EU, UK, Japan, Australia, NZ and India) covering composition of matter and/or medical use.  An improved formulation patent filed Q4 2017 (granted EU and US). In Q4 2022 a third patent was filed to cover APPA’s senomorphic effects in a wide range of age-related conditions.