Anthera’s blisibimod for lupus has experts uncertain over Phase III success; will not improve on Benlysta

05 Aug 2016

Anthera (NASDAQ:ANTH) has most experts uncertain over chances for blisibimod's Phase III success in systemic lupus erythematosus (SLE), contrary to rheumatologists' sentiments about the drug two years ago.

It is too difficult to predict how the drug will fare in the Chablis-SC1 Phase III trial (NCT01395745), as biologics notoriously perform poorly in late-stage SLE trials, they noted. In particular, Eli Lilly's (NYSE:LLY) tabalumab failure in September 2015 has dampened their enthusiasm for the MOA shared between tabalumab and blisibimod. Previously, experts interviewed had believed this MOA could be to blisibimod's advantage.

One analyst report, though, noted there is a strong rationale for BAFF inhibition in lupus and that trial design has improved greatly over time but expressed caution and neutrality about blisibimod due to the variable nature of the SLE patient population. Global sales for blisibimod are expected to reach USD 188m in 2024, according to BioPharm Insight data.

Anthera expects top-line Chablis-SC1 efficacy and safety data will be available prior to the annual American College of Rheumatology annual meeting in November. Anthera announced completion of interim analysis from Chablis-SC1 and that the study had passed futility analysis and would continue to completion, in a 10 February 2015 press release.

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