Pfizer and Eli Lilly have reported positive top-line results from a Phase III clinical trial of tanezumab in patients suffering from moderate-to-severe chronic low back pain (CLBP).
Tanezumab is a monoclonal antibody designed to selectively target, bind to and inhibit nerve growth factor (NGF). This is expected to prevent pain signals generated by muscles, skin, and organs from reaching the spinal cord and brain.
Pfizer and Lilly partnered in 2013 to co-develop and co-commercialise tanezumab globally.
Patients treated with 10mg tanezumab demonstrated statistically significant improvement in pain at 16 weeks when compared to placebo.
In case of 5mg dose of the investigational drug, the results showed a numerical improvement in pain, but no statistical significance.
Preliminary safety data demonstrated that the drug candidate was generally well tolerated during the 56-week treatment period of the trial, which also included a 24-week safety follow-up period.
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Pfizer Global Product Development tanezumab development team leader Ken Verburg said: “This study demonstrates the potential of tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines.
“This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analysing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain.”
The randomised, double-blind, placebo and active-controlled trial assessed the safety and efficacy of subcutaneous tanezumab for 16 weeks, and oral tramadol prolonged release (PR) for a total of 56 weeks.
Conducted in North America, Europe and Asia, the multi-centre, parallel-group Phase III study evaluated the change in the daily average Low Back Pain Intensity (LBPI) score from baseline to week 16 as the primary endpoint in a total of 1,832 patients.
Secondary efficacy endpoints involved assessment through 16 and 56 weeks, including comparisons to tramadol PR. The long-term safety of the drug was monitored through 80 weeks.