Allena Pharmaceuticals aligns with FDA on design of URIROX-2

Allena Pharmaceuticals announced that it has reached alignment with the FDA on both the design of URIROX-2, its second pivotal Phase 3 trial of reloxaliase in patients with enteric hyperoxaluria and its strategy to pursue a biologics license application, or BLA, submission for reloxaliase using the accelerated approval regulatory pathway. Allena’s URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2, which are designed to evaluate the safety and efficacy of reloxaliase in patients with enteric hyperoxaluria. URIROX-1 is currently enrolling patients, and Allena initiated URIROX-2 in Q4. The primary efficacy endpoint for URIROX-2 is the percent change from baseline in 24-hour urinary oxalate, or UOx, excretion measured during weeks 1-4, the same primary efficacy endpoint as URIROX-1. The FDA agreed that, if positive, biomarker data on 24-hour UOx excretion in URIROX-1 and URIROX-2 would be used for a BLA filing for accelerated approval of reloxaliase in enteric hyperoxaluria and that patients would continue in URIROX-2 to confirm clinical benefit during the long-term follow-up phase of the trial.
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