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SIMPLICITY Pediatric Clinical Study expected to begin in Q2 2016

The SIMPLICITY clinical study will be the first study that uses Sollpura™ powder for oral solution. Sollpura™ will be supplied in a convenient, easy-to-administer sachet (packet, similar to sugar), which is dissolvable in about one tablespoon of water. After an initial cohort of older patients, the SIMPLICITY study will focus on administration of Sollpura™ to pediatric patients ranging in age from 28 days to seven years.

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Phase 3 CHABLIS-SC1 Clinical Study Enrollment Completed

We are on track to provide topline efficacy and safety data from the CHABLIS-SC1 study during Q3 2016.

 

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Phase 3 CHABLIS 7.5 Clinical Study deployment continues on track

 

 

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Phase 2 BRIGHT-SC Data Planned for Q2 2016

Following our receipt of a termination notice from Zenyaku and the subsequent expiration of the 120-day termination period on January 7, 2016, we elected to stop further enrollment in the BRIGHT-SC clinical study. We have enrolled 57 patients, 45 of which remained in the study. We plan to conduct a proof-of-concept efficacy analysis when substantially all patients have received a minimum of six months of therapy in Q2 2016. This analysis will examine the effects of blisibimod versus placebo in the proportion of qualifying patients who achieve a complete response (“CR”) and a partial response (“PR”) at six months. CR is defined as the proportion of patients with baseline UPE of greater than two grams per 24 hours, achieving UPE of less than one gram per 24 hours or a 50% reduction in UPE from baseline, and the proportion of patients with baseline UPE between one and two grams per 24 hours, achieving UPE of less than one gram per 24 hours and a 50% reduction from baseline. PR is defined as the proportion of patients achieving urinary protein excretion (“UPE”) of less than or equal to one gram per 24 hours. Based on our previous discussions with regulatory authorities, we believe an evaluation of the change in proteinuria could serve as a surrogate endpoint to support an accelerated or conditional approval in various key commercial geographies. Following the completion of the BRIGHT-SC study we intend to explore a Special Protocol Assessment from the US FDA to ensure final concurrence on the willingness to consider proteinuria as a surrogate endpoint, the timing for completion of enrollment of the post marketing confirmatory study and blisibimod’s eligibility to receive orphan designation.

 

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