Five years after Eli Lilly stepped up with a $1.8 billion deal to bring Pfizer’s anti-NGF pain drug tanezumab back from limbo, the pharma giants are reporting that they successfully navigated a major Phase III study for the non-opioid therapy among patients suffering from osteoarthritis.
Researchers say that their drug hit three primary endpoints for pain, physical function and the patients’ overall assessment of their OA. Tapped by Pfizer as one of the leading late-stage drugs in their pipeline, the investigators also noted that “rapidly progressive osteoarthritis was observed in tanezumab-treated patients at a frequency of less than 1.5%, and was not observed in the placebo arm.”
That kind of safety signal, though, could come back to haunt them.
Evercore ISI’s Umer Raffat zeroed right in on it, telegraphing:
What we really need is a breakdown of RPOA1 vs RPOA 2 (much more severe form). Press release did NOT have this info and Pfizer is not disclosing currently.
– With that said, Pfizer does seem encouraged by the data, but likely needs longer follow up before being more definitive about its view on safety.
– As a reminder, press release notes 1.5% RPO rate … even if ALL these RPOs are Type 1, there is still that potential for conversion from Type 1 to Type 2 – especially since the trial reported today was 16 wk.
– A 3000 pt 52-wk trial is reporting this fall – that will be KEY.
There were no cases of osteonecrosis and no new safety signals to report.
The data are being held in reserve for a scientific conference. Meanwhile the partners have the drug in ongoing studies for several different conditions.
This is one of several powerful painkillers that were in the clinic 8 years ago, then suddenly shelved for some years as developers grappled with unexpected safety issues. And with the opioid crisis grabbing headlines around the world, expectations are still running high.
Back in 2010 tanezumab was widely considered one of the top prospects in the industry’s late-stage pipeline. The entire class of anti-NGF drugs was estimated by some analysts to be worth a potential $11 billion. Then the studies for the drug — as well as therapies at other major developers — were shelved after it became apparent that a group of patients were blowing out joints that then needed to be replaced.
Christi Shaw, senior vice president, Eli Lilly and Company and president, Lilly Bio-Medicines, noted:
“We look forward to continuing to advance tanezumab in our ongoing global Phase III development program, which includes six studies in approximately 7,000 patients with osteoarthritis, chronic low back pain and cancer pain.”
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