AKLRD > 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

2 Canine Trials

Client owned dogs diagnosed with established naturally occurring OA

  • Study 1 in 32 canine patients demonstrated significant pain relief
  • Study 2 in 60 canine patients demonstrated significant benefits over Meloxicam

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
  • 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
  • The Phase 2a results advances the ability to select the patients most likely to benefit from APPA and 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