Allena Pharmaceuticals (NASDAQ:ALNA) has completed enrollment in the first of two Phase 3 clinical trials of reloxaliase for the treatment of enteric hyperoxaluria.
Enteric hyperoxaluria occurs when an underlying gastrointestinal disorder causes excessive amounts of dietary oxalate to be absorbed. The disease typically presents with kidney stones and may lead kidney damage, etc.
Allena plans to evaluate reloxaliase, an oral oxalate-degrading enzyme, in two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2. The primary efficacy endpoint for both trials is the percent change from baseline in 24-hour urinary oxalate observed with reloxaliase, compared with placebo.
“We are excited to complete enrollment in this Phase 3 trial, as it brings us one step closer to achieving our foundational goal of providing reloxaliase as a first-in-class therapy for patients with enteric hyperoxaluria,” Dr. Louis Brenner, Allena’s president and CEO, said in a statement.
Allena expects to report top line data from URIROX-1 and URIROX-2 in the fourth quarter of 2019 and second half of 2021, respectively.