Both Regeneron Pharmaceuticals, Inc. REGN and its partner Teva Pharmaceutical Industries Ltd. TEVA suffered a setback with the FDA placing a clinical hold on a phase IIb study evaluating their experimental nerve growth factor (NGF) antibody, fasinumab, for chronic low back pain.
While Regeneron shares were down 1.3% on the news, Teva’s stock price dipped 2.7%.
Reason for the Clinical Hold
In addition to the clinical hold, the FDA has asked the companies to amend their study protocol after a case of adjudicated arthropathy (a type of joint disease) was observed in a patient receiving a high dose of fasinumab, who had advanced osteoarthritis at the beginning of the study. The study enrolled about 70% of the targeted 800 patients across four dose groups – placebo, 6 mg subcutaneously monthly, 9 mg subcutaneously monthly and 9 mg intravenously every two months.
Following the agency’s decision, Regeneron completed an unplanned interim review of results and stopped dosing in the study. While the interim analysis demonstrated clear indication of efficacy with improvement in pain scores in all fasinumab groups in comparison to placebo at the 8- and 12-week time points, preliminary safety results were found to be consistent with those previously reported on this class of treatments. Patients in the study will be followed for up to 36 weeks.
Given these study results, Regeneron and Teva are now working on a pivotal phase III study for chronic low back pain, excluding patients with advanced osteoarthritis. The pivotal program plan will be submitted for review with the FDA and other health authorities.
TEVA PHARM ADR Price
Osteoarthritis Pain Study Raises Concern
Meanwhile, Regeneron and Teva also provided an update from the phase II/III study on fasinumab for the treatment of osteoarthritis pain. The 36-week analysis of the phase II/III study raised some safety concerns as well. It has been observed that the incidence of adjudicated arthropathies is dose dependent with a higher rate of patients experiencing arthropathies in the higher-dose groups – 12% (9 mg), 7% (6 mg), 5% (3 mg), 2% (1 mg) and 1% (placebo).
In May 2016, Regeneron had reported 16-week data from the study in 421 patients. Patients received their last dose at 12 weeks and a follow-up analysis occurred at 36 weeks.
On the basis of these results, the companies are looking to advance only lower doses of fasinumab to the ongoing pivotal phase III program for osteoarthritis, pending discussion with the FDA and other health authorities.
The companies are now focused on making data-driven decisions on phase III fasinumab dosing, which will not only help maximize benefit for patients but also reduce side effects.
Meanwhile, updated data from the osteoarthritis pain phase II/III study and the chronic low back pain phase IIb study will be presented at forthcoming medical congresses.
We note that the latest setback came less than a month after Regeneron had announced a collaboration with Teva for the global development and commercialization of fasinumab. (Read more: Regeneron, Teva Collaborate to Develop Chronic Pain Drug)
We also remind investors that safety concerns have been associated with anti-NGF agents for years. Between 2010 and 2012, the FDA had put fasinumab and several other investigational agents against NGF on clinical hold due to joint-related adverse events. Though the concerned companies, including Regeneron, resumed studies last year, expectations from these classes of drugs have fallen due to long-term safety concerns.
REGENERON PHARM Price
Zacks Rank & Key Picks
Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Incyte Corporation INCY and Geron Corporation GERN. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Incyte’s earnings estimates for 2016 and 2017 were up a respective 22.2% and 6.6% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.
Geron has posted a positive earnings surprise in each of the four trailing quarters, bringing the average beat to 20.78%.
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