Phase III trial of PF 4383119 meets all co-primary endpoints in osteoarthritis pain.- Pfizer + Eli Lilly.

Pfizer and Eli Lilly announced that a 16-week Phase III study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of PF 4383119 (tanezumab), an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients� overall assessment of their OA, compared to those receiving placebo.

Tanezumab is part of an investigational class of pain medications known as nerve growth factor (NGF) inhibitors and in addition to OA pain, is being evaluated for chronic low back pain and cancer pain (due to bone metastases). Preliminary safety data showed that tanezumab was generally well tolerated, with approximately 1% of patients discontinuing treatment due to adverse events. Rapidly progressive osteoarthritis was observed in tanezumab-treated patients at a frequency of less than 1.5%, and was not observed in the placebo arm. There were no events of osteonecrosis observed in the trial. No new safety signals were identified.

Comment: In June 2017, Pfizer and Lilly announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tanezumab for the treatment of OA pain and CLBP. Tanezumab is the first NGF inhibitor to receive Fast Track designation, a process designed to facilitate the development and expedite the review of new therapies that treat serious conditions and fill unmet medical needs.