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

Pfizer and Eli Lilly announced complete results from a Phase III study evaluating the efficacy and safety of subcutaneous administration of PF 4383119 (tanezumab), an investigational humanized monoclonal antibody, in patients with osteoarthritis (OA) pain treated for 16 weeks. The study met all three co-primary efficacy endpoints, demonstrating that among patients with moderate-to-severe OA pain of the knee or hip, both dosing regimens of tanezumab were associated with a statistically significant improvement in pain, physical function and patient�s global assessment of their OA, compared to placebo. The drug showed a reduction in pain from baseline at 16 weeks of 68% for 2.5 mg dose and 70.4% for 2.5 + 5 mg dose, in more than 30% of patients.

In the study, nasopharyngitis, pain in extremity and paresthesia (tingling or numbing) were the most common adverse events (AEs of at least 3%) and had a higher frequency in both tanezumab treatment groups compared to placebo-treated patients. Tanezumab was generally well tolerated, with 0.4 percent and 1.3 percent of patients in the tanezumab 2.5 mg and 2.5 + 5 mg arms, respectively, discontinuing treatment due to AEs; 1.3 percent of patients in the placebo arm discontinued treatment due to AEs. These data were presented during a late-breaking oral session at the 2018 American College of Rheumatology/Association of Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting.

Comment: In June 2017, Pfizer and Lilly announced that the 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.