Regeneron and partner Teva announced that osteoarthritis patients would be excluded from future fasinumab research last night after the US Food and Drug Administration (FDA) imposed a clinical hold on the study, which was assessing the drug as a chronic lower back pain treatment.
“The US FDA has placed the Phase 2b study in chronic low back pain on clinical hold and requested an amendment of the study protocol after observing a case of adjudicated arthropathy in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry.”
The firms added that although preliminary analysis indicates fasinumab’s safety profile is consistent with earlier studies they “plan to design a pivotal Phase 3 study in chronic low back pain that excludes patients with advanced osteoarthritis.”
A Regeneron spokeswoman confirmed that the firm is continuing to evaluate the results to determine the cause of the adjudicated arthropathy.
The clinical hold comes a month after Regeneron and Teva teamed up to develop and commercialize fasinumab in a deal that will see the Israeli drug firm pay $250m (€227m) upfront and R&D costs of up to $1bn.
Outside the US Teva will be responsible for development and commercialization in all territories excluding Japan, Korea and nine other Asian countries where development will be carried about by Mitsubishi Tanabe Pharma under a separate agreement with Regeneron.
Fasinumab is a fully human monoclonal antibody. It targets a protein called nerve growth factor (NGF), which plays a role in the regulation of pain signalling.