Friday, June 29, 2012

Targeted failure. Again.


It looks like we have a good (or bad) tradition that once a month a new experimental targeted medicinal product fails in clinical trials. Very often these drugs are very complicated biologicals with very “sexy” story why they actually “are best and should be successful”. This time we have blisibimod which is:

Blisibimod (also known as A-623, formerly AMG 623) is a selective antagonist of B-cell activating factor (BAFF, also known as B-lymphocyte stimulator or BLyS), being developed by Anthera Pharmaceuticals as a treatment for systemic lupus erythematosus. It is currently under active investigation in clinical trials.

MechanismBlisibimod is a fusion protein consisting of four BAFF binding domains fused to the N-terminus of the fragment crystallizable region (Fc) of a human antibody.

BAFF is involved in B-cell survival, activation, and differentiation. Elevated levels of BAFF have been associated with several B-cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjögren’s syndrome, Graves’ disease, and Hashimoto's thyroiditis. Blisibimod binds to BAFF and inhibits interaction with BAFF receptors, thus decreasing B-cell survival and proliferation throughout the body. Improvements in disease activity have been observed in patients with systemic lupus erythematosus and rheumatoid arthritis following treatment with BAFF inhibitors in clinical trials.

And what a failure:

NEW YORK (AP) -- Shares of Anthera Pharmaceuticals Inc. plummeted Thursday after the company said its experimental lupus treatment blisibimod failed in a clinical trial, and changed its development plans for the drug.

THE SPARK: Anthera said blisibimod did not meet its goals in the study, because two of the three doses it studies were not effective when compared to a placebo. The company said patients who received 200 milligrams of blisibimod per week experienced improvement, but those who received 100 milligrams per week or 200 milligrams per month did not do significantly better than patients who were given a dummy shot.

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