By Mark Terry
Pfizer and Eli Lilly and Company announced that their tanezumab hit two out of three co-primary endpoints in one dose and all three with a higher dose in patients with moderate-to-severe osteoarthritis (OA) pain in a Phase III trial.
Tanezumab is a humanized monoclonal antibody that inhibits NGF. NGF had increased levels as the result of injury, inflammation or chronic states of pain. It is believed that by inhibiting NGF, the drug may prevent pain signals created by muscles, skin and organs from reaching the spinal cord and brain.
In the Phase III trial, the drug was compared to placebo for 24 weeks in patients with moderate-to-severe OA pain of the knee or hip. Patients enrolled in the trial had reported inadequate pain relief or intolerance to at least three different classes of pain medications previously, and on average had OA for six years or more. The trial was run in Europe and Japan.
The patients receiving 2.5 mg of the drug met two of the three protocol-defined co-primary efficacy endpoints. They showed a statistically significant improvement in pain and physical function. However, the patients’ overall evaluation of their OA wasn’t statistically different than placebo. The patients receiving 5 mg of the drug met all three co-primary endpoints at 24 weeks.
“These findings build on the previously reported positive Phase III 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,” stated Ken Verburg, 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.”
About 27 million people in the U.S. have been diagnosed with OA. It is a progressive joint disease. Treatments currently available for the pain associated with OA don’t always meet the needs of patients, who test out various therapies to find relief. Tanezumab’s mechanism of action is different than other pain medications, including opioids and nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, in studies it has not shown a risk of addiction, misuses or dependence.
The Phase III program for tanezumab includes six trials in about 7,000 patients with OA pain, chronic low back pain (CLBP) and cancer pain due to bone metastases. Previous results from a Phase III trial evaluating subcutaneous administration of the drug for 16 weeks was reported earlier. That trial met all three co-primary efficacy endpoints at both 2.5 mg and 2.5/5 mg doses.
Pfizer and Lilly inked their co-development and co-commercialization deal in 2013. In June 2017, the U.S. Food and Drug Administration (FDA) granted the drug Fast Track designation for OA pain and CLBP, the first NGF inhibitor to receive that designation.
“For many people, living with osteoarthritis pain can limit their ability to function, which can force them to make compromises in everyday life,” stated Christi Shaw, president of Lilly Bio-Medicines. “Lilly and Pfizer have a shared commitment to advance the care of people living with chronic pain, and we see the potential of tanezumab as an innovative, non-opioid option to improve the treatment of osteoarthritis pain, a debilitating, progressive condition.”