Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi announced that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo. The study, called SARIL-RA-TARGET, evaluated the efficacy and safety of two subcutaneous sarilumab doses versus placebo, added to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy in RA patients who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR).
The SARIL-RA-TARGET trial enrolled 546 TNF-IR patients who were randomized to one of three treatment groups self-administered subcutaneously (SC) every other week (Q2W): sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo, in addition to DMARD therapy. Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in both co-primary endpoints (p greater than 0.001):
(1) Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20 percent improvement (ACR20), were as follows: 61 percent in the sarilumab 200 mg group; 56 percent in the sarilumab 150 mg group; and 34 percent in the placebo group, all in combination with DMARD therapy.
(2) Improvement in physical function, as measured by change from baseline in the Health Assessment Question-Disability Index (HAQ-DI) at week 12.
The most frequently reported adverse events included infections (30, 22 and 27 percent in the 200 mg, 150 mg and placebo groups respectively) and injection site reactions (8, 7, 1 percent in the 200 mg, 150 mg and placebo groups respectively). Serious infections were uncommon (1, 0.6 and 1 percent in the 200 mg, 150 mg and placebo groups respectively). Reduction in neutrophil count was the most common lab abnormality. No unexpected safety findings were observed.
Two additional trials from the Phase 3 program, SARIL-RA-EASY and SARIL-RA-ASCERTAIN, also met their primary endpoints:
- SARIL-RA-EASY enrolled 217 patients and was designed to evaluate the technical performance and usability of the sarilumab autoinjector device. There were no product technical failures with the autoinjector, the primary endpoint of the study.
- SARIL-RA-ASCERTAIN was a 202 patient safety calibrator study, designed to assess the safety of two subcutaneous doses of sarilumab and tocilizumab infusion in combination with DMARDs in patients with RA who were TNF-IR. There were no clinically meaningful differences between the treatment groups in serious adverse events and serious infections.
Detailed results from all three SARIL-RA trials will be presented at future medical congresses. (Original Source)
Shares of Regeneron closed yesterday at $512.77 . REGN has a 1-year high of $516.81 and a 1-year low of $269.50. The stock’s 50-day moving average is $467.90 and its 200-day moving average is $430.23.
On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report released yesterday, Canaccord Genuity analyst John Newman reiterated a Buy rating on REGN, with a price target of $600, which represents a potential upside of 17.0% from where the stock is currently trading. Separately, on the same day, Argus’ John Eade reiterated a Buy rating on the stock and has a price target of $560.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Newman and John Eade have a total average return of 8.1% and 21.6% respectively. Newman has a success rate of 56.5% and is ranked #606 out of 3607 analysts, while Eade has a success rate of 92.0% and is ranked #44.
The street is mostly Bullish on REGN stock. Out of 9 analysts who cover the stock, 7 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $536.63, which represents a slight upside potential from current levels.
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.