Partnering

Based upon pre-clinical and clinical data APPA has the potential to be a groundbreaking treatment for human and animal osteoarthritis

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 results in inflammation, pain and loss of function in OA.  In addtion APPA has shown it can slow the progression of OA 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 and this will be finalised with the development partner.