Regeneron adds more positive PhIII data for its NGF program — but safety is still a big concern
Two years after fasinumab hit its first late-stage bar, Regeneron is standing by its “high-risk, high reward” bet on the NGF antibody. But while new Phase III data solidified the potential reward, the risk is still threatening to blow it all up.
Regeneron execs and analysts alike now have their eyes set on a rival drug from Pfizer and Eli Lilly, whose fate at the FDA will likely set the scene for the class.
The news comes from FACT OA1 and FACT OA2, which compared fasinumab to placebo over 16 weeks and 24 weeks, respectively, for co-primary endpoints measuring pain and physical function among osteoarthritis patients. Across the trials, the 1 mg monthly dose induced statistically significant improvements in both.
Investigators also reported that fasinumab seemed to offer more benefits than non-steroidal anti-inflammatory drugs, although the differences were merely “nominal.”
All of it shows that fasinumab can have a place in the pain field, where NSAIDs aren’t helping all of the millions of people living with osteoarthritis pain and opioids come with their own problems and concerns.
But even George Yancopoulos, Regeneron’s typically outspoken president and CSO, admitted that the safety profile remains the biggest concern, as initial safety analyses suggest an increase in arthropathies (joint issues) among those who took the drug.
SVB Leerink analyst Geoffrey Porges heard it as a “fairly tepid defense of the drug’s profile,” but isn’t making any calls until data from a long-term safety study are out early next year.
At Teva — the development and commercialization partner — CEO Kåre Schultz is notably more upbeat.
“If you look at it holistically and look at the product itself, the strong improvement it has on pain and physical function, which has proven beyond doubt in the clinical trial, and then the associated improvement, which is that you will be avoiding alternative therapies that have a risk of abuse,” he said on an analyst call. “And in that sense, from a commercial point of view, if it does end up getting approved by FDA, then I think it has a strong commercial opportunity here to the benefit of many patients suffering from severe pain.”
Will the FDA approve it? With what constraints? As the two companies prepare their filing, Regeneron chief Len Schleifer said they will be paying attention in December, when regulators are expected to hand down a decision on tanezumab.
Pfizer and Eli Lilly have taken the 2.5 mg dose to regulators, having shelved the 5 mg dose. Scrapping higher doses appear to be a common theme in the class; in the first Phase III (which has since been converted into the long-term safety study), Regeneron was also forced to abandon the two high-dose arms due to side effects.