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 development of disease modifying drugs in OA has traditionally been incredibly difficult because the end points are so challenging. Regulatory guidance from the FDA now states that as well as showing a disease modifying effect, any new OA drug targeting disease modification must also demonstrate symptomatic pain relief. Since this guidance update, a number of potential drugs in late-stage development have been failed.
A number of medicines remain in development pursuing a disease modifying label, however these are either administered intra-articularly (into the joint) or sub-cutaneously (under the skin). Intra-articular injections are painful and offer localised benefits only to the joint being injected, and both routes come with associated costs and infrastructure requirements. By contrast, oral medicines have a simple route of administration, are cost effective and offer a systemic-wide benefit.
No other new chemical entity (NCE) currently in development can offer an oral, well-tolerated, treatment targeting multiple signalling pathways with the objective of reducing pain and slowing disease progression in OA. This makes APPA the only oral – and most advanced – candidate for OA in the biopharma pipeline.
It is AKLRD’s intention to partner further development of APPA for human OA beyond the current phase 2 program.