-Blisibimod Secondary Endpoints May Provide Differentiation to Benlysta-
Report is Available for Download at: www.lifesciadvisors.com/clients/anthera
With top-line results for Anthera Pharmaceuticals’ (NASDAQ: ANTH) Phase 2b PEARL-SC study due by the end of this month, we find it worthwhile to review the PEARL-SC study design to anticipate how blisibimod may differentiate itself from the recently approved lupus drug, Benlysta. We believe that the study results may present opportunities for blisibimod to address issues that Benlysta has experienced in its relatively short time on the market.
Following the halting of the Phase 3 VISTA-16 study in mid-March, the shares of Anthera have fallen almost 70% in a matter of 3 months. With the stock current trading at approximately 2x cash and blisibimod Phase 2b results due out by the end of this month in lupus, a very large addressable market, it could be argued that the stock is trading at a significant discount.
Interim Analyses – B-cell Data and Safety & Efficacy Review Were All Positive. On October 25, the last patient was enrolled in the PEARL-SC study and earlier in the year in December 2011, an independent review of this study’s biomarker data confirmed that the weekly and monthly subcutaneous doses of blisibimod resulted in a statistically significant reduction of B-cells. On March 5, Anthera announced that the PEARL-SC DSMB met for the fourth time to review all available safety data and recommended that the study continue as planned without modification. Also during the interim analysis, an independent statistician completed an efficacy review after the 350th patient reached the 24-week time-point and also recommended that the study continue to completion. More recently, Anthera announced the patients dosing for the PEARL-SC study was completed on April 25, 2012.