Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today provided an update on regulatory discussions for the global development of blisibimod. End of Phase 2 discussions with the US Food and Drug Administration (FDA) have been completed and will allow for the submission of Phase 3 protocols and the initiation of registration studies. Earlier in 2012, Anthera received a written response from the European Medicines Agency (EMA) providing similar development feedback for the blisibimod program.
"We appreciate the FDA's rapid response to our development proposal for blisibimod. We will incorporate their comments and begin the initiation of our Phase 3 lupus program," said Paul F. Truex, Anthera's President and CEO. "The PEARL-SC clinical study provided meaningful insight into the importance of selecting an appropriate patient population while also defining a meaningful endpoint. We are grateful the FDA found this approach to be acceptable for further study and look forward to bringing blisibimod one step closer to patients in need."
The Phase 3 studies (CHABLIS-SC1 and CHABLIS-SC2) will be multicenter, placebo-controlled, randomized, double-blind studies 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. Patients will be treated in the controlled part of each study for 52 weeks after which they will have the option to receive additional treatment as part of an open-label, long-term, follow-up safety study. The primary endpoint of the CHABLIS studies will be a Systemic Lupus Erythematosus Response Index (SRI) including the requirement of an eight-point or greater improvement from baseline in the SELENA/SLEDAI disease measurement (SRI-8).