Successful Phase II/III trial for fasinumab for osteoarthritis pain of hip and knee.-Regeneron

Regeneron Pharmaceuticals, Inc. announced positive topline results from a placebo-controlled Phase II/III study evaluating fasinumab in patients with moderate-to-severe osteoarthritis pain of the hip or knee who have a history of inadequate pain relief or intolerance to current analgesic therapies. At 16 weeks, patients treated with all four doses of fasinumab, an investigational Nerve Growth Factor (NGF) antibody, demonstrated a statistically significant improvement in pain relief, the primary endpoint of the study, as well as improvements in the secondary measure evaluating physical function. This is the first trial of a convenient subcutaneous monthly regimen. The U.S. study enrolled 421 adult patients with moderate-to-severe osteoarthritis of the hip or knee who had a history of inadequate pain relief or intolerance to acetaminophen, and at least one oral nonsteroidal anti-inflammatory drug (NSAID) and an opioid.

Patients in the study were experiencing significant pain at baseline with an average pain score of 6.3 on a 10-point scale. Patients were evaluated for pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in addition to other measures. Patients were randomized to one of five treatment groups in a 1:1:1:1:1 fashion: fasinumab 1mg, 3mg, 6mg, 9mg, or placebo, all delivered subcutaneously every 4 weeks through week 12, with the primary efficacy measured at week 16. Following week 16, patients are being studied for an additional 20 weeks off treatment. On the primary endpoint, fasinumab-treated patients reported less pain at 16 weeks when compared to placebo on the 10- point WOMAC subscale for pain.The safety analysis includes all results at the time of the primary efficacy analysis; complete data will be reported when all patients complete the full 36 weeks. Overall incidence of adverse events, including serious and severe events, was similar across the fasinumab groups and placebo.

Comment: Fasinumab is a non-opioid pain therapy that works by blocking nerve growth factor (NGF) to treat chronic pain.