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Pfizer, Lilly’s osteoarthritis pain drug meets co-primary endpoints in phase 3 study

PBR Staff Writer Published 19 July 2018

Pfizer and Eli Lilly’s osteoarthritis (OA) pain drug, tanezumab, has met all three co-primary endpoints in a phase 3 study.

The study showed that patients who secured 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.

In June 2017, Pfizer and Lilly secured fast track designation from the US Food and Drug Administration (FDA) for tanezumab to treat OA pain and chronic low back pain (CLBP).

Tanezumab is an investigational humanized monoclonal antibody, and potential first-in-class and non-opioid treatment being assessed for OA pain, CLBP and cancer pain.

Pfizer global product development’s tanezumab development team leader Ken Verburg said: “We are encouraged by these results, which speak to the potential of tanezumab as a non-opioid treatment option for pain reduction and improvement in physical function in people living with osteoarthritis pain.”

Preliminary safety data demonstrated that tanezumab was generally well tolerated, with around 1% of patients discontinuing treatment due to adverse events.

The 6-week randomized, double-blind, placebo-controlled, multicenter and parallel-group trial has been designed to asses the efficacy and safety of subcutaneous administration of tanezumab compared to placebo in patients with OA of the knee or hip.

In the trial, the patients have been recruited with moderate to severe OA pain who had experienced inadequate pain relief with other treatment options for OA pain or were unable to take other pain medications.

The study randomized 698 patients to three treatment groups in a 1:1:1 ratio to secure two injections over the 16-week study, once every eight weeks.

The drug is said to work by selectively targeting, binding to and inhibiting NGF. It will help to keep pain signals produced by muscles, skin and organs from reaching the spinal cord and brain, by inhibiting NGF.

In 2013, Pfizer and Lill signed worldwide co-development and co-commercialization agreement to advance the development of tanezumab.

Eli Lilly and Company senior vice president and Lilly Bio-Medicines president Christi Shaw said: “We look forward to continuing to advance tanezumab in our ongoing global Phase 3 development program, which includes six studies in approximately 7,000 patients with osteoarthritis, chronic low back pain and cancer pain.”


Image: Pfizer world headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.