"While the results of the CHABLIS-SC1 interim futility analysis remain blinded to Anthera, we are very pleased that the study has passed this critical milestone and now look forward to finishing enrollment later this year," said Dr.
Prior to the interim analysis and in response to recent input from the Company's
"Based on the wealth of new information regarding the treatment of SLE and BAFF inhibition, we are fortunate to have had the opportunity to adjust our trial design," said Dr.
Anthera has also completed a Scientific Advice Process meeting with the
"We are pleased by the feedback from the EMA on the IgAN development program, which supports our global approach in IgAN. This comes at a time when we are actively expanding our recruitment efforts throughout the world," said Dr.
Anthera is developing blisibimod, a selective inhibitor of B-cell activating factor (BAFF), to explore its clinical utility in various autoimmune diseases including systemic lupus erythematosus (SLE) and IgA nephropathy. Blisibimod is a novel FC-fusion protein, or peptibody, and is distinct from an antibody. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. Abnormal elevations of B-cells and BAFF may lead to an overactive immune response, which can damage normal healthy tissues and organ systems. Multiple clinical studies with BAFF antagonists have reported the potential benefit of BAFF inhibitors in treating patients with lupus and IgAN.
About Sollpura (liprotamase)
Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas. Unlike other enzyme products for EPI, Sollpura's chemical characteristics make it ideal for formulation as either a capsule or sachet product for co-administration with a variety of food products.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 Anthera's public filings with the
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