Teva Pharmaceutical Industries and Regeneron Pharmaceuticals said that a phase 3 study evaluating nerve growth factor (NGF) antibody fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip met both co-primary endpoints and all key secondary endpoints.
According to the partners, fasinumab-treated patients had faced significantly less pain and had considerably improved their functional ability from baseline in comparison to placebo at week 16 primary efficacy analysis.
Following the primary efficacy assessment at week 16, patients have been put on therapy for a further 36 weeks, and after which there will be a subsequent 20-week off study drug follow-up period for additional safety assessment of fasinumab.
George D. Yancopoulos – President and Chief Scientific Officer of Regeneron said: “We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program 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.”
Fasinumab, which was invented by Regeneron Pharmaceuticals using its VelocImmune technology, targets nerve growth factor (NGF), a protein known for playing a key role in the regulation of pain signaling.
In 2016, Regeneron Pharmaceuticals and Teva Pharmaceutical Industries signed a global collaboration to develop and commercialize fasinumab.
As per the deal, Teva paid an upfront amount of $250 million to Regeneron and had agreed to share equally in the global commercial value, and also ongoing research and development costs of around $1 billion.
The global collaboration does not apply to Japan and 10 other Asian countries where Mitsubishi Tanabe Pharma holds exclusive development and commercial rights for fasinumab.
Currently, Regeneron and Teva are taking in patients with chronic pain due to osteoarthritis of the knee or hip in three phase 3 trials. Included in these trials is one that will evaluate the long-term safety of fasinumab and two trials that will compare the drug to standard pain therapies.