Lilly/Pfizer's Osteoarthritis Pain Drug Succeeds in 2nd Study
Eli Lilly and Company LLY and its partner Pfizer Inc. PFE announced that their NGF inhibitor, tanezumab, met all co-primary endpoints in a phase III study, evaluating it in patients with osteoarthritis (“OA”) pain.
Lilly’s shares have rallied 17.1% in the past six months against the industry’s decrease of 2.5%.
The phase III study evaluated two dosages – 2.5 mg or 5 mg – of tanezumab, subcutaneously administered every eight weeks for 24 weeks in patients with moderate-to-severe OA pain who have experienced inadequate relief or are intolerant to analgesics and suffering from the disease for more than six years. Top-line data from the study evaluating the non-opioid candidate showed that treatment with 5mg of tanezumab led to a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA – the three primary endpoints – compared to placebo at 24 weeks.
The 2.5 mg dose achieved improvement of statistical significance compared to placebo in pain and physical function while a statistical difference was not observed for patients’ overall assessment of their OA.
Data announced in July 2018 from the first phase III study in OA pain showed that tanezumab achieved improvement of statistical significance in similar endpoints at week 16.
. The positive results from the two studies highlight the potential of the candidate as a treatment option for a difficult-to-treat patient population. An estimated 11 million suffer from moderate-to-severe OA, which indicates significant prospects for the candidate.
We remind investors that Regeneron Pharmaceuticals, Inc. REGN and Teva Pharmaceutical Industries Limited TEVA are also developing a NGF antibody, fasinumab for treating OA.
Tanezumab is also being evaluated for chronic low back pain and cancer pain (due to bone metastases). Notably, Lilly has been working on building its pipeline and finding novel treatment options for chronic pain.
In September 2018, Lilly launched Emgality, its CGRP antibody, from its pain portfolio for the preventive treatment of migraine in the United States during September, which could emerge as a significant contributor to long-term growth. Another migraine candidate, lasmiditan, is under review. In December 2018, Lilly also entered into an agreement with Massachusetts-based privately held Hydra Biosciences to add the latter’s pre-clinical pain candidate to its pain portfolio.
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