Date: 2014-05-12
Type of information:
phase: 2b
Announcement: results
Company: AstraZeneca (UK)
Product: sifalimumab
Action
mechanism: Sifalimumab (formerly MEDI-545) is an investigational human monoclonal antibody that targets IFN-α, a type of inflammatory cytokine in the body known to play a role in the development of SLE. Previous studies have shown that high levels of type I IFN-α are correlated with more severe disease activity in SLE patients, and early studies of sifalimumab have demonstrated that this agent blocks signaling of all interferon alpha subtypes.
Disease: moderate/severe systemic lupus erythematosus
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On May 12, 2014, AstraZeneca announced MedImmune’s sifalimumab met primary endpoints in Phase IIb study. This antibody is being investigated as a treatment for patients with moderate/severe systemic lupus erythematosus (SLE or lupus). The study met its primary endpoint of percentage of subjects that responded by the SLE Responder Index (SRI-4) at Day 365. Clinically important improvements in organ-specific outcome measures (joint, skin) and patient reported outcomes were also observed. In the study, three doses of sifalimumab were evaluated against placebo when added to stable standard of care therapy in patients with moderately to severely active lupus despite standard of care therapy. In addition to efficacy in the primary endpoint, there is a broad-based body of clinical evidence supporting the efficacy of sifalimumab. The study achieved two secondary endpoints at specific doses - improvement in skin (rashes) as measured by CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) and improvement in fatigue. Sifalimumab demonstrated an overall acceptable safety profile, with a numerical increase in the incidence of Herpes Zoster reactivations. The company anticipates presenting additional study results at a future medical conference later this year.
