Pfizer and Eli Lilly have been testing tanezumab in patients with moderate-to-severe chronic low back pain (CLBP) in a Phase 3 study, with certain success, as tanezumab 10 mg met the primary endpoint by reducing pain at 16 weeks compared to placebo.
The companies said Tuesday in a press release that tanezumab 5 mg arm showed a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis.
Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid pain medications known as nerve growth factor (NGF) inhibitors.
Ken Verburg, tanezumab development team leader, Pfizer Global Product Development, said: “This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain.”
Christi Shaw, president, Lilly Bio-Medicines, said: “Lilly and Pfizer recognize the unmet needs for those living with this life-altering and debilitating condition, and continue to advance tanezumab as an innovative non-opioid treatment for these patients.”
As said in the press release, in addition to CLBP, the ongoing Phase 3 program for tanezumab includes studies in osteoarthritis (OA) pain and cancer pain (due to bone metastases). One additional Phase 3 study in OA pain and one additional Phase 3 study in CLBP will read out this year, the companies said.