DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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STRUCTURAL FORMULA
Monomer sequence
GCKWDLLIKQ WVCDPLGSGS ATGGSGSTAS SGSGSATHML PGCKWDLLIK 50
QWVCDPLGGG GGVDKTHTCP PCPAPELLGG PSVFLFPPKP KDTLMISRTP 100
EVTCVVVDVS HEDPEVKFNW YVDGVEVHNA KTKPREEQYN STYRVVSVLT 150
VLHQDWLNGK EYKCKVSNKA LPAPIEKTIS KAKGQPREPQ VYTLPPSRDE 200
LTKNQVSLTC LVKGFYPSDI AVEWESNGQP ENNYKTTPPV LDSDGSFFLY 250
SKLTVDKSRW QQGNVFSCSV MHEALHNHYT QKSLSLSPGK 290
Disulfide bridges
2-13 2′-13′ 43-54 43′-54′ 69-69′ 72-72′ 104-164 104′-164′ 210-268 210′-268′
Protein (synthetic cytokine BAFF-binding domain fragment) fusion protein with
immunoglobulin G1 (human Fc fragment), dimer
http://www.ama-assn.org/resources/doc/usan/blisibimod.pdf SEE MORE
March 27, 2013 /
Anthera Pharmaceuticals, Inc. , a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced it has initiated the CHABLIS-SC1 Phase 3 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of systemic lupus erythematosus (lupus). Lupus is a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain and major organ complications.
The Phase 3 CHABLIS-SC1 study is a multicenter, placebo-controlled, randomized, double-blind study designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with clinically active SLE (SELENA-SLEDAI > 10) who have not achieved optimal resolution of their disease with corticosteroid use. The study will enroll patients from Latin America, Asia Pacific and Commonwealth of Independent States who will be randomized to receive blisibimod or placebo for 52 weeks after which they will have the option to receive blisibimod therapy in an open-label, long-term, follow-up safety study. The study will enroll approximately 400 patients and the primary endpoint will be a Systemic Lupus Erythematosus Response Index-8 (SRI-8). An SRI-8 responder is defined as a patient who has achieved a reduction in SELENA-SLEDAI equal to or greater than 8 points, and no new BILAG A or two B organ domain scores, and no increase in Physician’s Global Assessment (PGA) of greater than 0.3 on a three point scale. As part of the CHABLIS-SC1 clinical study an independent statistician will conduct interim analyses to validate key study assumptions. A summary of these analyses will be published later in 2013.
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.[1] It is currently under active investigation in clinical trials.[2]
- “A-623: BAFF Peptibody for the Treatment of Lupus”. Anthera Pharmaceuticals, Inc. Retrieved 2011-07-08.
- “Anthera Initiates Expanded and Extended PEARL-SC Phase 2b Clinical Study in Lupus With A-623 – A Subcutaneous Dual Inhibitor of Membrane and Soluble B-Cell Activating Factor (BAFF or BLyS)” (Press release). Anthera Pharmaceuticals, Inc.. 29 July 2010.
New Drug Approvals 