Pfizer (NYSE:PFE)/Eli Lilly’s (NYSE:LLY) tanezumab for osteoarthritis (OA) of the hip and knee may face hurdles to clear long-term efficacy and safety benchmarks, experts said.
While positive Phase III (NCT02697773) data announced on 18 July is encouraging, prior safety signals from tanezumab’s Phase II proof-of-concept trial (NCT00394563) – released in 2009 – has experts still cautious of incidences of rapidly progressive osteoarthritis (RPOA).
The industry awaits results from the long-term Phase III trial (NCT02528188), expected by 1H19, and experts are cautious of its overall risk/benefit profile. Even though adverse effects (AEs) were seen in a small amount of Phase II patients, there is a clear link to tanezumab, they added.
Tanezumab is an anti-nerve growth factor (NGF) monoclonal antibody working to reduce joint inflammation in OA whilst also providing pain relief. The class of drugs – including Regeneron (NASDAQ:REGN)/Teva’s (NYSE:TEVA) fasinumab and Johnson & Johnson’s (NYSE:JNJ) fulranumab – were put on clinical hold from 2010 to 2015 due to the aforementioned safety concerns. Despite the hold being lifted in 2015, fulranumab was discontinued, placing a cloud over tanezumab’s attempts for a resurrection.
Analyst sentiments are mixed with some noting protocol adjustments should boost safety, while others pause on the omission of a breakdown of RPOA incidences in the most recent data release.
Experts, similarly, note looming questions of RPOA have not yet been answered by the new data, drawing caution on the long-term profile.
Analysts predict USD 500m in peak sales potential, while anti-NGFs are expected to be a USD 2bn class by 2025 in OA and other indications.