Eli Lilly and Company and Pfizer presented complete results from a Phase III clinical trial of tanezumab in patients with osteoarthritis (OA) at the 2018 American College of Rheumatology/Association of Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting in Chicago.
Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF). NGF levels increase from injury, inflammation or in chronic pain. The companies believe that by inhibiting NGF, tanezumab prevents pain signals produced by muscles, skin and organs from reaching the spinal cord and brain. This is a novel mechanism of action than opioids and other pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs). In trials, it shows less risk of addiction, misuse or dependence.
The trial was a 16-week randomized, double-blind, placebo-controlled, multicenter, parallel-group trial in patients with OA of the knee or hip. There was a 24-week safety follow-up period.
The trial looked at 698 patients broken into three treatment groups in a 1:1:1 ratio. They received two injections over the 16-week period, once every eight weeks. One group received two doses of placebo, another group received two 2.5 mg doses of tanezumab, and the final group received one 2.5 mg dose of tanezumab followed by a single 5 mg dose eight weeks later.
More than half of the patients receiving tanezumab had a 50 percent or greater decrease in pain.
“The results demonstrated by tanezumab in this study are particularly meaningful, given that patients had moderate-to-severe pain and were unable to achieve adequate pain relief with other treatment options, including opioids and NSAIDs,” stated Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “Our goal is to be able to offer tanezumab as a potential non-opioid treatment option for these patients suffering from osteoarthritis pain.”
The companies see this drug as an alternative to opioids. There is currently an epidemic of opioid abuse in the U.S. In 2018, opioid overdoses killed 49,000 people, according to the National Institute on Drug Abuse (NIDA)
If the drug is approved by regulators, it will be the first non-opioid treatment for osteoarthritis. The companies plan to submit to the U.S. Food and Drug Administration (FDA) for approval in 2019.
Osteoarthritis affects more than 30 million people in the U.S. It is a progressive disease that results in joint degeneration, which leads to joint pain, stiffness, and swelling.
Tanezumab had fairly low adverse side effects. In the 2.5 mg and 2.5/5 mg arms of the trial, 0.4 percent and 1.3 percent of patients discontinued treatment because of adverse events. In the placebo arm, 1.3 percent discontinued treatments from adverse events.
Adverse events included the common cold, pain in the extremities, and tingling or numbness.
“Pfizer and Lilly each have a long-standing heritage of scientific innovation in developing novel pain treatments and a shared commitment to the development of tanezumab,” stated Christi Shaw, senior vice president, Eli Lilly and president, Lilly Bio-Medicines. “These initial results from our Phase III program for tanezumab are promising, and we’re eager to gain further insights as additional data report out next year.”
Tanezumab is involved in six Phase III trials in approximately 7,000 patients with OA pain, chronic low back pain (CLBP) and cancer pain due to bone metastases. More readouts from these trials are expected to start in the first half of next year.
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