Regeneron has unveiled encouraging top-line data from a placebo-controlled Phase II/III study assessing its investigational Nerve Growth Factor antibody fasinumab in patients with moderate-to-severe uncontrolled osteoarthritis pain of the hip or knee.
The US trial enrolled 421 adult patients 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, who were all experiencing significant pain at baseline, were randomised to receive one of five treatment groups: fasinumab 1mg, 3mg, 6mg, 9mg, or placebo, all delivered subcutaneously every 4 weeks through week 12, with the primary efficacy measured at week 16.
Results showed a statistically-significant improvement in pain relief after 16 weeks’ treatment with the drug at all doses, with change from baseline ranging from -3.35 to -3.65, as well as improvements in the secondary measure evaluating physical function, Regeneron reported.
On the safety side, the overall incidence of adverse events, including serious and severe events, was similar across the fasinumab groups and placebo. As expected with antibodies to NGF, there was an increase in certain neuro- musculoskeletal adverse events in the fasinumab treatment groups (17 percent combined fasinumab; 6 percent placebo) including arthralgia, paraesthesia, hypoaesthesia, and peripheral edema), the firm said, and noted that a full safety analysis will be reported after patients complete the full 36 weeks.
“Chronic osteoarthritis is a common cause of pain, disability, and productivity loss for older adults,” said George Yancopoulos, chief scientific officer of Regeneron and President of Regeneron Laboratories, and stressed that here is “a real need for new, non-opioid pain therapies that can provide relief to patients without the toxicity and potential for abuse of currently available opioid treatments”.