Fasinumab Phase III Osteoarthritis Trial Meets Endpoints
Tuesday, August 28, 2018
Source: Global Pharma Update
Results from the trial showed that the drug met all primary and key secondary endpoints at week 16 primary efficacy analysis.
It was observed that subjects administered with the drug candidate experienced significantly less pain and improved functional ability, compared to the placebo group.
Formulated by Regeneron using its VelocImmune technology, fasinumab is an investigational candidate that targets the nerve growth factor (NGF) protein associated with pain signalling regulation.
Fasinumab is being co-developed by Regeneron and Teva under a global collaboration agreement.
The randomised, double-blind, placebo-controlled phase III trial evaluated the safety and tolerability of subcutaneous 1mg dose of fasinumab every four or eight weeks over 52 weeks of active treatment.
The co-primary endpoints are change in pain and physical function from baseline at week 16. Fasinumab therapy continued for additional 36 weeks, followed by a 20-week follow-up study. The long-term primary safety analysis is set to be carried out at 72 weeks.
Upon analysis of interim data, the drug candidate was found to be generally well tolerated. The adverse events (AEs) were similar to those observed in prior fasinumab trials.
Regeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “We are encouraged by this data and look forward to advancing our pivotal phase III fasinumab programme in patients with osteoarthritis of the knee or hip who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids.”
Currently, fasinumab is being assessed in a total of three phase III trials for treating chronic pain caused by OA of the knee or hip.
One of the trials is designed to investigate the drug candidate’s long-term safety, while the remaining two studies compare it to standard pain therapies.