Yesterday, Israel-based Teva Pharmaceuticals and their partner Regeneron, announced that the US Food and Drug Administration (FDA) has put their Phase IIb clinical trial for a chronic pain medication on hold. The decision was made after a patient in the study developed severe joint inflammation.
In addition to mandating the hold on the clinical trial, the FDA also called for a study protocol amendment. The pain drug – fasinumab – is being assessed as a possible treatment for chronic low back pain and osteoarthritis pain.
The setback prompted Regeneron and Teva to conduct an unplanned interim analysis of the study results, and all dosing was stopped. They found that at the eight and 12 week timepoints, the fasinumab group saw an improvement in pain scores.
“We are making data-driven decisions on Phase 3 fasinumab dosing that we believe will maximize potential benefit for patients in need, while minimizing the likelihood of side effects,” said Dr. George D. Yancopoulos, Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. “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.”
Before receiving the clinical hold order, the clinical trial has enrolled around 70 percent of their 800 patient target. Study participants were assigned to one of three dosage groups, or a fourth placebo control group.
According to a press release issued by the companies, patients enrolled in the trial will be followed for up to 36 weeks. The patient who experienced the adverse event was participating in the high dose treatment arm.
“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,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva. “”We look forward to advancing clinical development for this promising novel therapy.”
Based on positive results of a previous Phase 2/3 clinical trial of fasinumab, Teva and Regeneron plan to push the lower doses of the drug into further trials, which will be subject to FDA approval. Both companies are collaborating on the global development and commercialization of the investigational chronic pain drug.