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Regeneron and Teva Show Positive Topline Phase 3 Results in Osteoarthritis

Significant reduction in pain and improvement in physical function (Image: Osteoarthritis Foundation International).

Osteoarthritis is the most common form of arthritis, affecting over 30 million adults in the US according to the CDC. The pain from osteoarthritis can be debilitating, preventing even basic daily tasks, impeding the ability to work and greatly diminishing quality of life. Osteoarthritis was the second most costly health condition treated at US hospitals in 2013, accounting for $16.5 billion, or 4.3% of the combined costs for all US hospitalizations.

Source: Osmosis.

Regeneron REGN and Teva TEVA announced positive topline results this morning from their Phase 3 study of fasinumab in patients with chronic pain from osteoarthritis of the knee or hip. Fasinumab is an antibody that targets nerve growth factor (NGF), a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in the synovial fluid of patients with chronic pain conditions.

The data from the study, a subset of a larger, long-term trial that involves 52 weeks of active treatment, showed that fasinumab-treated patients experienced significantly less pain and significantly improved functional ability compared to placebo patients after week 16 of the study. These were the co-primary endpoints of the study, which also achieved all key secondary endpoints. The table below summarizes the results. Note that lower scores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) indicate lower pain and lower loss of functionality.) The data show significant improvement in those patients taking fasinumab every 8 weeks and even greater improvement in the every-four-weeks population.

Topline Efficacy Results from Phase 3 Study1
Placebo Fasinumab 1 mg every 8 weeks Fasinumab 1 mg every 4 weeks
(n=214) (n=215) (n=217)
Change in pain at week 16 vs. baseline (least squares mean)2 -1.56 -2.25 -2.78
(p=0.0019) (p<0.0001)
Change in physical function at week 16 vs. baseline (least squares mean)3 -1.37 -2.1 -2.57
(p=0.0011) (p<0.0001)

1. Approximately 85% of sub-study patients had osteoarthritis of the knee; 2. As measured by the WOMAC pain subscale score (range: 0-10); 3. As measured by the WOMAC physical function subscale score (range: 0-10). Lower numbers indicate lower pain and lower loss of function. Sources: Regeneron and Teva.

The data is welcome news for investors who had reason for concern after Regeneron announced in May 2018 with its Q1 results that “an independent Data Monitoring Committee monitoring the ongoing safety and efficacy of the fasinumab clinical trials
recommended that the higher dose-regimens [of
3 mg every four weeks and 6 mg every eight weeks] be discontinued based on the risk benefit assessment and that the
program may continue with the lower dose-regimens of fasinumab.”

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-steroidal anti-inflammatory drugs or opioids.

– George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron.

Regeneron and Teva have been working together since 2016 on developing fasinumab. Under their deal, Teva paid Regeneron $250 million upfront, and the companies agreed to share equally in the global commercial value, excluding 11 Asian countries that are covered under a previous deal with Mitsubishi Tanabe Pharma MTZPY, as well as ongoing research and development costs of approximately $1 billion.

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