With candidate fasinumab, Teva and Regeneron were trying to dodge repeated delays, increased scrutiny and labeling limitations that have taken a toll on other programs in the NGF antibody class. But now that the FDA has placed a clinical hold on the prospect, that’s just what it’s going to get, one analyst predicts.
Leerink Partners analyst Geoffrey Porges is reducing the med’s probability of success to 0% in his models and stripping out all sales and future milestone payment contributions. He expects fasinumab to have “all of the liabilities” of its predecessors and befall the same fate--and the way he sees it, Regeneron’s continued investment in the program, despite its development trip-ups, “does not reflect positively” on the company’s “development decision,” he wrote in a note to clients.
His criticism followed an announcement from the companies that U.S. regulators had held up the trial, with the agency asking for “an amendment of the study protocol” after seeing a case of adjudicated arthropathy--a joint disease--in one patient receiving a high dose of the candidate med for chronic lower back pain.
The blip isn’t the first misfire for the class. The FDA also placed a clinical hold on Eli Lilly‘s and Pfizer’s anti-NGF candidate, tanezumab, in 2011, and the pair only last year restarted trials of the prospect.
But analysts predict the pain market is a lucrative one--in the multibillion-dollar range--for drugmakers that can get their treatments all the way to market. With opioid abuse ravaging the U.S., there’s a wealth of opportunity for safe and effective pain treatments.
Meanwhile, it’s the second recent piece of bad clinical trial news for Regeneron. In late September, the drugmaker said a combo trial of its blockbuster Eylea had underperformed the med on its own at treating wet age-related macular degeneration.