Regeneron and Teva’s experimental drug halted by FDA clinical hold
pharmafile | October 17, 2016 | News story | Manufacturing and Production | Regeneron, Teva, back pain, osteoarthritis
Regeneron Pharmaceuticals and Teva Pharmaceuticals had only just agreed a deal worth a potential $2.6 billion to co-develop Regeneron’s fasinumab only to be struck by bad news in a Phase II trial. They had formed their partnership on 21 September and were hit by a clinical hold, by the FDA, on 17 October.
Fasinumab is a drug developed to provide pain relief from chronic lower back pain for patients. The drug offers a potential alternative to opiate-based medication, which can be addictive. Fasinumab is an antibody that blocks the activity of a protein, called nerve growth factor, which is involved in signalling pain.
The reason for the clinical hold is related to an individual patient who, prior to the study, had suffered advanced osteoarthritis and, when dosed with high levels of fasinumab, developed a case of adjudicated arthropathy. As a result of the FDA’s decision, Regeneron completed an analysis of results and has completely stopped the study. Though the news is initially troubling for both companies involved, they will be reassured that the drug displayed clear evidence of efficacy with improvement in pain scores over the placebo.
“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,” stated George D. Yancopoulos, M.D., Ph.D., 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.”
With this outcome to the trial, Regeneron and Teva will redesign their Phase III trial to exclude patients suffering from advanced osteoarthritis in the hope that this will minimise the risk of further damaging side-effects, allowing the FDA to green light future trials.
Ben Hargreaves
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