The placement of a clinical hold on a Phase IIb study by Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and its partner Teva Pharmaceutical Industries Ltd (ADR)(NYSE:TEVA) is a major setback for the two. The study was trying to establish an experimental nerve growth factor (NGF) antibody, fasinumab, for chronic low back pain. The situation may have caused the drop in Regeneron shares by 1.3%, and Teva’s stock price dipped 2.7%.
Reasons behind the Clinical Hold
The study rolled out to a target of 800 patients across four dose groups. The groups were placebo, 6 mg subcutaneously monthly, and 9 mg subcutaneously, which was on a monthly basis and 9 mg intravenously every two months. There was an observation of adjudicated arthropathy (a type of joint disease) on a patient who was receiving a high dose of fasinumab. Apparently, the patient had complex osteoarthritis at the beginning of the study. As a result, the companies will now be required by the FDA to amend their study protocol.
The agency’s decision prompted Regeneron to complete an unplanned review of results and at the same time stopped dosing in the study. But in all fasinumab groups, the interim analysis had an indication of efficacy and notable improvements in pain scores compared to placebo at the 8- and 12-week time points.
What next for the two companies?
As this unfolded, the duo also provided an update on Phase II/III study on fasinumab, which is used in the treatment of osteoarthritis pain. The 36-week analysis of phase II/III study, however, pointed out on some safety concerns the likes of the incidence of adjudicated arthropathies.
However, they will now embark on a pivotal Phase III study for chronic low back pain but with an exclusion of patients with advanced osteoarthritis. Meanwhile, the results of the chronic low back pain Phase IIb study and those of the osteoarthritis pain Phase II/III study will be presented at forthcoming medical congresses. The companies will also pick on a focus on making data-driven decisions on Phase III fasinumab dosing.
The latest setback is barely a month old, and it comes shortly after Regeneron made public its collaboration with Teva for the global development and commercialization of fasinumab.