The 16-week, double-blind, placebo-controlled, multicenter, parallel-group study included 698 patients who were randomized to 3 treatment groups: 2 doses of tanezumab 2.5mg; 1 dose of tanezumab 2.5mg followed by tanezumab 5mg, or 2 doses of placebo; each injection was administered once every 8 weeks. The co-primary efficacy endpoints were change from baseline at 16 weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale, the WOMAC Physical Function subscale, and the patient’s Global Assessment of OA.
Results showed that compared with placebo, patients in both tanezumab treatment groups experienced a statistically significant improvement in pain, physical function, and overall assessment of OA. “We are encouraged by these results, which speak to the potential of tanezumab as a non-opioid treatment option for pain reduction and improvement in physical function in people living with osteoarthritis pain,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development.“ With regard to safety, preliminary data showed that tanezumab was generally well tolerated and did not demonstrate a risk for addiction, misuse or dependence.
If approved, tanezumab has the potential to become a first-in-class treatment option for OA pain. Tanezumab works by selectively targeting, binding to and inhibiting nerve growth factor (NGF). This inhibition blocks pain signals from reaching the spinal cord and brain.
This novel therapy is also being evaluated for chronic low back pain and cancer pain. “We look forward to continuing to advance tanezumab in our ongoing global Phase 3 development program, which includes 6 studies in approximately 7,000 patients with osteoarthritis, chronic low back pain and cancer pain,” said Christi Shaw, senior vice president, Eli Lilly and Company and president, Lilly Bio-Medicines.