Both firms have announced that top-line results from a phase 3 study assessing tanezumab 2.5mg and 5mg.
Tanezumab is an investigational monoclonal antibody, which works by selectively targeting, binding to and inhibiting nerve growth factor (NGF).
The study has been designed to compare the long-term joint safety and 16-week efficacy of the investigational pain killer relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe OA of the hip or knee.
Tanezumab 5mg treatment arm achieved two of the three co-primary efficacy endpoints, showing a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs.
Patients who secured tanezumab 2.5mg did not achieve a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs.
Higher rate of joint safety events have been reported events in the tanezumab arms compared to NSAIDs at 80 weeks in the safety analysis.
Joint safety was a composite measure including adjudicated outcomes of rapidly progressive osteoarthritis (RPOA) type 1 or type, subchondral insufficiency fracture, osteonecrosis or pathological fracture.
Tanezumab 2.5 mg or 5 mg was administered subcutaneously (SC) every eight weeks, for a total of 56 weeks, in the study.
The randomized, double-blind, active-controlled, multicenter, parallel-group study assessed the safety and efficacy of SC administration of tanezumab for 56 weeks compared to NSAIDs in patients with moderate-to-severe OA. The trial was carried out across the world, including the US, Europe, Asia and Latin America.
In June 2017, Pfizer and Lilly secured fast track designation from the US Food and Drug Administration (FDA) for tanezumab to treat OA and chronic low back pain.
Pfizer Global Product Development’s tanezumab development team leader Ken Verburg said: “We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab.
“We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”