The CHABLIS-SC1 study was evaluated by an independent statistician to assess the SRI-6 response 24 weeks after the beginning of the trial.
Anthera is a biopharmaceutical firm committed to developing and commercializing products to address life-threatening and serious diseases such as IgA nephropathy, cystic fibrosis and systemic lupus erythematosus.
“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,” Dr. Colin Hislop, Anthera’s Chief Medical Officer, said in a press release.
In response to other Lupus studies with BAFF inhibitors, Anthera altered the primary endpoint of CHABLIS-SC1 from SRI-8 response to SRI-6 response, which had previously been a secondary endpoint of the study, leaving SRI-8 as a key secondary endpoint.
“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. The SRI-6 endpoint has a history of consistency across multiple trials and represents the best possibility for success. Maintaining the SRI-8 endpoint as a key secondary endpoint can maximize our commercial opportunity for the severe patients we are enrolling in the CHABLIS-SC1 study,” said Hislop.
Anthera recently concluded a Scientific Advice Process meeting with the European Medicines Agency (EMA) to address the development of blisibimod in the treatment of IgA Nephropathy (IgAN). Moreover, the company received a conditional market authorization application (MAA) in the European Union utilizing proteinuria as the primary endpoint. EMA gave recommendations to address the duration, need and durability of response for re-treatment in the company’s BRIGHT-SC study.
“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,” commented Hislop.