OA is the leading cause of chronic disability in older adults, costing the US more than $185 billion annually
Percentage of US adult population who were obese or severely obese in 2014, a significant risk factor for OA
No approved drugs can prevent, stop, or even slow the progression of OA
The global market for analgesics in Osteoarthritis is >$8bn and projected to reach $12.3bn by 2027, growing at a CAGR of 7.6%. Self medicated and prescribed analgesics have short term benefits due to diminishing efficacy. Steroid injections have only short term benefits.
Based upon pre-clinical and clinical data APPA has the potential to be a ground-breaking treatment for human and animal osteoarthritis.
APPA is the only NCE with a mechanism of action that targets the multiple signalling pathways in bone, cartilage and inflammation that are involved in OA, with potential for slowing the progression of the disease as demonstrated in two animal species.
The APPA phase IIa trial was designed to assess the efficacy of APPA in subjects with varying degrees of osteoarthritis and to identify those who would benefit the most. In a predefined subgroup, patients with more severe disease benefited with a statistically significant improvement in pain vs placebo. A post-hoc analysis identified that patients with greater pain and with OA in both knees, also benefitted with a significant improvement with APPA vs placebo.
The phase IIb development program is focused on patients with more severe disease and, because of its good tolerability profile, will also assess the effectiveness of a higher dose.
It is AKL’s intention to partner further development of APPA for human OA beyond the current phase IIb program. A phase III program has been developed in outline to assess efficacy in pain reduction, improvement in function and disease modification, measured through imaging and other proxy markers. This will be finalised with the development partner.