Allena Pharmaceuticals has signed an agreement with the Duke Clinical Research Institute (DCRI) for the URIROX-2 Phase III clinical trial evaluating the safety and efficacy of reloxaliase in the treatment of patients with enteric hyperoxaluria.
Allena’s URIROX-2 is one of two ongoing pivotal Phase III clinical trials evaluating the safety and efficacy of reloxaliase as a novel therapy.
DCRI will establish and lead an academic coordinating centre (ACC) for URIROX-2.
An academic steering committee (ASC) will also be set up to provide independent oversight and support investigator engagement for the trial.
Allena Pharmaceuticals president and CEO Louis Brenner said: “Alongside our work with patient advocacy groups, we expect that this partnership with the DCRI will increase the awareness of enteric hyperoxaluria in the medical community, enhance identification of patients for our clinical programme, and begin laying the foundation to support the potential future launch of reloxaliase.
“We look forward to working closely with DCRI as we seek to develop the first therapeutic for patients with this serious disorder.”
Allena’s URIROX programme comprises multi-centre, global, randomised, double-blind, placebo-controlled URIROX-1 and URIROX-2 trials designed to evaluate the safety of reloxaliase.
The URIROX-2 study will enrol a total of 400 patients to assess reloxaliase over a minimum treatment period of two years.
The trial’s primary efficacy endpoint for URIROX-2 is the percent change from baseline in 24-hour UOx excretion during weeks 1 to 4.
Allena initiated the study in the fourth quarter of last year.
Hyperoxaluria is a metabolic disorder characterised by elevated urinary oxalate levels, typically caused by the liver as a result of a genetic defect.
In January, Allena signed an alignment with the US Food and Drug Administration (FDA) on the design of the URIROX-2 Phase III trial of reloxaliase.
The company intends to pursue a Biologics Licence Application (BLA) submission for the drug.