Regeneron Pharmaceuticals and partner Sanofi announced positive results from its late-stage study evaluating its rheumatoid arthritis candidate.
The companies said that the Phase III study of sarilumab 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. Sarilumab is an investigational, fully human IL-6 receptor antibody, designed to block the binding of IL-6 to its receptor that interrupts the resultant cytokine-mediated inflammatory signaling.
In the study, known as SARIL-RA-TARGET, 546 patients who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR) were enrolled and randomized to one of the treatment groups self-administered subcutaneously (SC) every other week. The patients received either sarilumab 200 mg, sarilumab 150 mg, or placebo, in addition to DMARD therapy. Both groups receiving the investigational antibody demonstrated clinically relevant and statistically significant improvements compared to the group receiving the placebo in both co-primary endpoints. Patients receiving sarilumab 200 mg and sarilumab 150 mg achieved ACR20 at 24 weeks of 61 percent and 56 percent, respectively, while only 34 percent of patients in the placebo group achieved ACR20 at 24 weeks.
Additionally, the company said that patients receiving the investigational drug showed improvement in physical function, as measured by change from baseline in the Health Assessment Question-Disability Index (HAQ-DI) at week 12.
The companies said that two additional trials from its Phase III program also met their primary endpoints. One of these evaluated the performance and usability of the drug’s autoinjector device. In the trial there were no product technical failures with the autoinjector, the primary endpoint of the study. In a separate trial, researchers assessed the safety of two subcutaneous doses of the drug and tocilizumab infusion in combination with DMARDs in RA patients.
Sanofi and Regeneron said that they will seek approval for the new RA drug from the US Food and Drug Administration (FDA) later this year. The companies plan to present detailed results from the trial at a future medical congresses.
The drug was developed using Regeneron’s VelocImmune antibody technology.
Source: Regeneron Pharmaceuticals, Inc.
Last updated: 5/21/15; 4:15pm EST