Alder BioPharmaceuticals has regained the worldwide pharma licensing rights to clazakizumab, a humanized monoclonal antibody to the pro-inflammatory cytokine IL-6, from Bristol-Myers Squibb based on BMS' decision to end further development following a portfolio prioritization and not based on any new or unexpected efficacy or safety data or technical issues.
Alder plans to continue the clinical development of the therapeutic antibody in autoimmune/inflammatory disease based on the positive study results reported to date.
All clazakizumab treatment arms, both as monotherapy and in combination with methotrexate (MTX), met the primary endpoint of ACR20 response at 12 weeks, compared to MTX alone. Clazakizumab had promising rates of low disease activity and remission based on Disease Activity Score (DAS)28, Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) criteria in the study that included MTX and anti-TNF comparator arms. Remission rates by CDAI and DAS28-CRP were numerically greater for clazakizumab than for the active comparator anti-TNF, adalimumab.
The safety profile of clazakizumab was consistent with the known pharmacology of IL-6 blockade.
The results of a Phase IIb dose-ranging clinical trial of clazakizumab in patients who suffer from active psoriatic arthritis (PsA) will be the focus of an oral presentation at the American College of Rheumatology's 2014 Annual Meeting, which takes place Nov. 14-19 in Boston.
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