Anthera Pharmaceuticals selected the Merck BioManufacturing Network in the U.K. to produce large-scale GMP clinical and precommercial supplies of A-623. The drug is a fusion protein, or peptibody, being studied in Phase II as a treatment for systemic lupus erythematosus (SLE).
A-623 is an inhibitor of B-cell activating factor (BAFF), which promotes B-cell survival in humans. Abnormal levels of soluble and membrane BAFF and resulting B-cell elevations have been implicated in a number of autoimmune diseases including SLE, Sjogren syndrome, and rheumatoid arthritis, Anthera points out.
The firm says that it has begun enrollment in PEARL-SC, a Phase IIb study in lupus patients. This randomized, double-blind trial is designed to demonstrate that inhibition of both membrane-bound and soluble BAFF with A-623 will improve patient clinical outcomes as measured by a composite SLE responder index.
“Establishing a rapid and high-quality supply of A-623 for our current and future clinical programs is a critical element of our strategic plan and provides a number of potential development options,” states Paul F. Truex, president and CEO of Anthera. “The selection of the Merck BioManufacturing Network provides world-class, large molecule manufacturing capabilities at all stages of production with the necessary expertise to accelerate the development of A-623 in systemic lupus erythematosus and other autoimmune diseases.”
Merck BioManufacturing Network is a CMO providing development and manufacturing services for biologics to pharmaceutical and biotechnology companies. It comprises the operations at Billingham, U.K. (formerly Avecia Biologics), and at Research Triangle Park, NC (formerly Diosynth Biotechnology).
Anthera’s clinical pipeline also includes Phase III A-002 and Phase II A-001. Both compounds inhibit an enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions including acute coronary syndrome and acute chest syndrome as well as chronic diseases such as stable coronary artery disease, according to the firm.