Tanezumab, a monoclonal antibody against nerve growth factors was first discovered and developed in 2006. The medication is still under trials as a treatment for pain.
It has already passed the Phase III trials for knee pain and hip pain due to Osteoarthritis. It is also undergoing Phase II trials for the treatment of pain issues, such as chronic lower back pain, bone cancer pain and interstitial cystitis.
On February 19, 2019, the co-development partners- Eli Lilly and Pfizer made an announcement regarding the Phase III trial results.
Phase III Trials
Patients with moderate to severe chronic low back pain
Tanezumab 10 mg
To observe the efficacy of Tanezumab 5 mg and 10 mg in comparison with placebo for treatment of pain
1832 participants who had experienced chronic lower back pain for at least 3 months
Patients were randomized (3:2:2:2) to 4 study arms:
Tanezumab 5 mg every 8 weeks to week 56;
Tanezumab 10 mg every 8 weeks to week 56;
Tramadol prolonged release daily to week 56;
Placebo every 8 weeks to week 16, at which point these patients were switched randomly to either Tanezumab 5 mg or Tanezumab 10 mg every 8 weeks to week 56.
Route of drug administration:
Tanezumab was delivered by subcutaneous injection and Tramadol was given orally.
Measurement of Results:
The primary endpoint was changed in the daily average Low Back Pain Intensity (LBPI) score from baseline to week 16, which was measured on an 11-point scale.
1. The investigators observed rapidly progressive osteoarthritis (RPOA) among 1.4% of patients receiving tanezumab compared to 0.1% of patients in the other treatment groups.
2. There was a 6: 1 ratio of RPOA type 1 to RPOA type 2 in patients receiving Tanezumab.
3. While not observed in other treatment groups, investigators reported subchondral insufficiency fracture in 0.4% and total joint replacement in 0.7% of patients in tanezumab treatment arms.
4. There were no events of osteonecrosis in the study.
Treatment with Tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo (however, 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis)
Statements from the Developers of Tanezumab
“This study demonstrates the potential of Tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines,” stated Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain,” said Verburg.
“Many patients living with chronic low back pain suffer from constant pain, which significantly impacts their ability to perform everyday tasks,” said Christi Shaw, president, Lilly Bio-Medicines, in a press release. “Lilly and Pfizer recognize the unmet needs for those living with this life-altering and debilitating condition, and continue to advance tanezumab as an innovative non-opioid treatment for these patients.”