Regeneron’s fasinumab hit the mark in a late-stage study assessing patients with chronic pain from osteoarthritis (OA) of the knee or hip. At 16 weeks patients experienced significantly less pain and also showed significantly improved functional ability from baseline.
Regeneron’s fasinumab hit the mark in a late-stage study assessing patients with chronic pain from osteoarthritis (OA) of the knee or hip. At 16 weeks patients experienced significantly less pain and also showed significantly improved functional ability from baseline.
The Phase III study, which was co-conducted by Teva Pharmaceuticals, compared two different dose schedules of fasinumab (1 mg injection every four or eight weeks) against placebo. The trial hit all primary and key secondary endpoints, the companies announced this morning. This particular study is a sub-study of a larger Phase III trial that involves one-year of active treatment. The majority of the patients in the trial, about 85 percent, had osteoarthritis of the knee.
Topline results showed both dosing arms had a significant advantage over placebo in addressing both pain and physical function. Data released by Teva and Regeneron showed the dosing of fasinumab every four weeks had a slight advantage in addressing both pain and function than the every eight-week dose.
Fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions. It is estimated that 30 million people suffer pain from osteoarthritis, and the same number of people with chronic low back pain in the United States.
George D. Yancopoulos, president and chief scientific officer of Regeneron, said the company is encouraged by the data from the late-stage trial. Yancopoulos said the company intends to advance the program in order to bring the treatment to patients.
Regeneron and Teva said they intend to present detailed results from this study at an upcoming medical conference.
Following the efficacy assessment at 16 weeks, the companies said trial patients will continue to take the doses of fasinumab for an additional 36 weeks. That period will be followed by a 20-week off-period study to assess safety. So far, interim safety data has shown that fasinumab was well-tolerated with similar adverse events observed in previous trials with fasinumab. About 5 percent of patients who have taken both dosing regimens of fasinumab in the trial discontinued use. The safety data that was announced today is interim and preliminary in nature, the companies said.
Earlier this year, an Independent Data Monitoring Committee (IDMC) monitoring the safety and efficacy of ongoing fasinumab trials recommended discontinuing two higher dose regimens, 3 mg every four weeks and 6 mg every eight weeks.
The two companies are currently studying the efficacy of fasinumab in three Phase III trials. One is assessing the long-term safety of fasinumab and two trials are comparing fasinumab to standard pain therapies.
As Regeneron and Teva advance the fasinumab study, the companies are trying to stay ahead of Eli Lilly and Pfizer who are jointly developing the anti-NGF tanezumab osteoarthritis pain. Last year the U.S. Food and Drug Administration granted tanezumab Fast Track designation, the first NGF inhibitor to receive the designation.
