Second phase III study of ALLN-177 enteric hyperoxaluria
Phase of Trial: Phase III
Latest Information Update: 02 Jan 2019
At a glance
- Drugs Reloxaliase (Primary)
- Indications Hyperoxaluria
- Focus Registrational; Therapeutic Use
- Acronyms URIROX-2
- Sponsors Allena Pharmaceuticals
- 02 Jan 2019 According to an Allena Pharmaceuticals media release, this trial was initiated in the fourth quarter of 2018.
- 02 Jan 2019 Status changed from planning to recruiting, according to an Allena Pharmaceuticals media release.
- 02 Jan 2019 According to an Allena Pharmaceuticals media release, the company reached an agreement with the U.S. FDA regarding the design of Phase III program, under which 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.