Regeneron/Teva pain drug fasinumab on target in phase 3
Pharmaphorum Media Limited | August 17, 2018
Regeneron and Teva have announced positive top-line phase 3 results from their fasinumab, as the companies chase Pfizer and Lilly in the race to market a new class of non-opioid painkillers. Fasinumab is from a class of drugs targeting nerve growth factor (NGF), which plays a central role in the regulation of pain signaling. The FDA had trials of NGF drugs on hold twice because of concerns that they caused nerve damage – but research resumed in 2015. This allowed Regeneron and Teva to continue with trials on fasinumab, and Pfizer and Eli Lilly to resume trials into tanezumab. The latest results from Regeneron and Teva are from a sub-study in a larger, long-term trial that involves 52 weeks of treatment in patients with osteoarthritis (OA) pain. Approximately 85% of sub-study patients had OA of the knee. The primary efficacy data were assessed at 16 weeks and the primary safety analysis of the larger long-term trial will occur at 72 weeks, after a year of active treatment and 20-week follow-up periods.