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Regeneron, Teva plan to reduce fasinumab dose in phase 3 trial
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Regeneron Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd. announced the companies will reduce the dose of fasinumab and exclude patients with advanced osteoarthritis in an upcoming fasinumab phase 3 trial, according to a company release.
“We are making data-driven decisions on phase 3 fasinumab dosing that we believe will maximize potential for patients in need, while minimizing the likelihood of side effects,” George, D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the release. “We look forward to working with global health authorities to advance this important investigational therapy for patients with often difficult-to-treat osteoarthritis pain and chronic low back pain.”
After observing a case of adjudicated arthropathy in a patient with advanced osteoarthritis (OA) who received high-dose fasinumab, the FDA suspended the fasinumab phase 2b study and requested an amendment of protocol, the release noted. In response, Regeneron completed an interim review of results and stopped dosing. Despite the case of adjudicated arthropathy, fasinumab showed improvement in pain scores after 12 weeks. In addition, preliminary safety results were consistent with the drug class. Based on these results, Regeneron and Teva plan to design a phase 3 study that excludes patients with advanced OA.
In the phase 2/3 OA pain study, researchers assessed 421 patients and looked for subchondral insufficiency fractures, osteonecrosis and rapidly progressive OA. After 36 weeks, adjudicated arthropathy incidence was found in 12% of the 9-mg group, 7% of the 6-mg group, 5% of the 3-mg group, 2% of the 1-mg group and 1% of the placebo group. After observing this dose-dependent incidence, Regeneron and Teva plan to advance only lower doses to the phase 3 trial.
“We believe fasinumab represents an important potential innovation for patients with osteoarthritis pain and chronic low back pain who currently have clear unmet need and limited treatment options,” Michael Hayden, MD, PhD, president of Global Research and Development and chief scientific officer at Teva, said in the release. “We look forward to advancing clinical development for this promising novel therapy.”
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