Teva and Regeneron report positive Phase 3 results for Fasinumab in osteoarthritis pain management

Teva Pharmaceutical Industries and Regeneron Pharmaceuticals have announced successful outcomes from their phase 3 study of fasinumab, a nerve growth factor (NGF) antibody, in patients suffering from chronic pain due to osteoarthritis (OA) of the knee or hip. The study met both co-primary endpoints and all key secondary endpoints, signaling a potential new treatment option for individuals with limited therapeutic choices.

The clinical trial demonstrated that patients treated with fasinumab experienced significant reductions in pain and improvements in functional ability compared to those receiving a placebo at the 16-week primary efficacy analysis. These findings mark a significant advance in the management of chronic osteoarthritis pain, a condition that commonly leads patients to rely on non-steroidal anti-inflammatory drugs (NSAIDs) or opioids.

George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, expressed optimism about the findings: “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.”

Following the initial 16-week assessment, the study protocol includes an additional 36 weeks of therapy, after which a 20-week off-drug follow-up period is conducted for further safety evaluations. This extended study period is crucial to understanding the long-term implications and safety profile of fasinumab as a chronic pain treatment.

Fasinumab was developed by Regeneron using its proprietary VelocImmune technology. The drug specifically targets nerve growth factor (NGF), a protein integral to pain signaling. This targeted approach offers a novel mechanism for pain management outside the traditional drug classes, potentially reducing the dependency on opioids.

In 2016, Regeneron and Teva entered into a global collaboration agreement to develop and commercialize fasinumab. As part of the agreement, Teva made an upfront payment of $250 million to Regeneron and agreed to share global commercial value and ongoing research and development costs, which are estimated to be around $1 billion. Notably, the collaboration excludes Japan and 10 other Asian countries, where Mitsubishi Tanabe Pharma retains exclusive rights.

Currently, Regeneron and Teva are enrolling patients in three phase 3 trials. These include a long-term safety study and two efficacy trials comparing fasinumab to standard pain therapies. The outcomes of these trials could potentially redefine the approach to treating osteoarthritis pain, offering new hope to millions suffering from this debilitating condition.