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AstraZeneca PLC (AZN) Announces Results Of Phase 2b Studies

5/13/2014 11:48:35 AM

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May 13, 2014 -- AstraZeneca today announced that two key molecules in MedImmune's respiratory, inflammation and autoimmune (RIA) portfolio - mavrilimumab and sifalimumab - met their primary endpoints in respective phase II studies, demonstrating further pipeline progress in core therapeutic areas.

MedImmune is the global biologics research and development arm of AstraZeneca. Top-line results from the phase IIb study of mavrilimumab, an investigational monoclonal antibody that inhibits a key pathway in the development of rheumatoid arthritis (RA), achieved its primary endpoints. In the Phase llb study of a methotrexate inadequate responder RA population (EARTH EXPLORER-1), 326 patients with moderate and severe RA were treated for six months with either mavrilimumab (low, medium or high dose) or placebo in addition to standard methotrexate background therapy.

The co-primary endpoints of the American College of Rheumatology (ACR) response of ACR20 and Disease Activity Score (DAS28) were met with all mavrilimumab doses confirming the efficacy demonstrated in the previous Phase IIa study (EARTH). The high dose was the most effective with an ACR20 response at week 24 of 73.4 percent vs 24.7 percent for placebo (p 3 percent) included headache, nasopharyngitis (common cold), hypertension, bronchitis and worsening of RA.

MedImmune also announced top-line results from the Phase II study of sifalimumab (MEDI-545), a novel monoclonal antibody 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 Z - See more at:

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