HAYWARD, Calif., July 29 /PRNewswire-FirstCall/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has initiated PEARL-SC, the Phase 2b study of A-623, a novel inhibitor of B-Cell Activating Factor, or BAFF, for the treatment of Systemic Lupus Erythematosus (lupus). Lupus patients suffer from a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain, major organ complications, and cardiovascular disease.
PEARL-SC is a, randomized, double-blind, placebo-controlled, Phase 2b clinical study that will enroll up to 600 patients in up to 60 centers worldwide. Patients will be randomized into three active treatment arms and one placebo treatment arm for a minimum of 24 weeks. The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in the systemic lupus erythematosus (SLE) responder index, a recently recognized FDA endpoint for demonstrating clinical efficacy. The SLE rates from the treated group will be pooled and compared to those from the placebo group. Secondary endpoints will include safety, improvement in other clinical assessment scores, patient response versus baseline disease severities, resolution of fatigue, steroid utilization, and time to flare. As previously announced, a blinded interim biomarker analysis will be conducted early in the study to establish the appropriate drug effect on B-Cells and potentially remove any arm that is not demonstrating a biologic effect.
"This improved PEARL-SC study represents a significant advancement in the study of A-623 for patients with lupus. We were pleased the FDA has endorsed a more meaningful study targeting a clinical endpoint which incorporates the latest knowledge of B-Cell modulation and potential impact on the various aspects of lupus," stated Paul Truex, Anthera's President and Chief Executive Officer.
"Recent clinical studies have provided hope that the treatment of lupus with BLyS inhibition can be significantly improved over currently available treatment options. The PEARL-SC study design includes insights from our Scientific Advisory Board and will provide more meaningful information about the potential of A-623 in lupus patients," stated Colin Hislop, M.D., Anthera's Chief Medical Officer. "By inhibiting both soluble and membrane bound forms of BAFF, A-623 could provide an additional therapeutic benefit in lupus with the convenience of subcutaneous dosing."
About B-Cell Activating Factor (BAFF or BLyS) and A-623
BAFF(or BLyS) has been associated with a wide range of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of A-623, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. A-623 is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to A-623 in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as secretory phospholipase A2 (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 (CAD). Anthera's Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF or BLyS), which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the Securities and Exchange Commission, including Anthera's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Juliane Snowden of Burns McClellan, Inc., [email protected] or 212.213.0006.
SOURCE Anthera Pharmaceuticals, Inc.
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PEARL-SC is a, randomized, double-blind, placebo-controlled, Phase 2b clinical study that will enroll up to 600 patients in up to 60 centers worldwide. Patients will be randomized into three active treatment arms and one placebo treatment arm for a minimum of 24 weeks. The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in the systemic lupus erythematosus (SLE) responder index, a recently recognized FDA endpoint for demonstrating clinical efficacy. The SLE rates from the treated group will be pooled and compared to those from the placebo group. Secondary endpoints will include safety, improvement in other clinical assessment scores, patient response versus baseline disease severities, resolution of fatigue, steroid utilization, and time to flare. As previously announced, a blinded interim biomarker analysis will be conducted early in the study to establish the appropriate drug effect on B-Cells and potentially remove any arm that is not demonstrating a biologic effect.
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"This improved PEARL-SC study represents a significant advancement in the study of A-623 for patients with lupus. We were pleased the FDA has endorsed a more meaningful study targeting a clinical endpoint which incorporates the latest knowledge of B-Cell modulation and potential impact on the various aspects of lupus," stated Paul Truex, Anthera's President and Chief Executive Officer.
"Recent clinical studies have provided hope that the treatment of lupus with BLyS inhibition can be significantly improved over currently available treatment options. The PEARL-SC study design includes insights from our Scientific Advisory Board and will provide more meaningful information about the potential of A-623 in lupus patients," stated Colin Hislop, M.D., Anthera's Chief Medical Officer. "By inhibiting both soluble and membrane bound forms of BAFF, A-623 could provide an additional therapeutic benefit in lupus with the convenience of subcutaneous dosing."
About B-Cell Activating Factor (BAFF or BLyS) and A-623
BAFF(or BLyS) has been associated with a wide range of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of A-623, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. A-623 is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to A-623 in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as secretory phospholipase A2 (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 (CAD). Anthera's Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF or BLyS), which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the Securities and Exchange Commission, including Anthera's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Juliane Snowden of Burns McClellan, Inc., [email protected] or 212.213.0006.
SOURCE Anthera Pharmaceuticals, Inc.
