Top-line results were announced from a second Phase 3 study evaluating tanezumab (Pfizer and Lilly), an investigational treatment for moderate-to-severe osteoarthritis (OA) pain.
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF). In this OA study (A4091057), patients with moderate-to-severe OA pain of the knee or hip (N=849) were randomized to 1 of 3 treatment groups: tanezumab 2.5mg, tanezumab 5mg, or placebo; a dose was subcutaneously administered once every 8 weeks over the 24-week treatment period. The co-primary endpoints of the study were changes from baseline at 24 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 at 24 weeks, a statistically significant improvement in pain and physical function was observed in patients treated with tanezumab 2.5mg and 5mg compared with placebo; as for the patient’s Global Assessment of OA, a statistically significant difference was only noted in the tanezumab 5mg arm. With regard to safety, treatment with tanezumab was found to be well-tolerated; the study included a 24-week safety follow-up period.
“These findings build on the previously reported positive Phase 3 results in patients with osteoarthritis pain and add to the growing body of evidence supporting tanezumab as a potential innovative treatment option for this difficult-to-treat patient population,” said Ken Verburg, PhD, tanezumab development team leader, Pfizer Global Product Development. “We look forward to sharing data from additional ongoing studies evaluating tanezumab for osteoarthritis pain and chronic low back pain in the coming months.”
In addition to OA, tanezumab is also being investigated for the treatment of chronic low back pain and cancer pain due to bone metastasis.
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