Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
Phase of Trial: Phase III
Latest Information Update: 04 Dec 2019
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At a glance
- Drugs Reloxaliase (Primary)
- Indications Hyperoxaluria
- Focus Registrational; Therapeutic Use
- Acronyms URIROX-2
- Sponsors Allena Pharmaceuticals
- 04 Dec 2019 According to an Allena Pharmaceuticals media release, company plans to re-engage with the FDA in early 2020 to discuss modifications to this trial design. These enhancements could potentially include reducing the target enrollment in URIROX-2, conducting an earlier interim analysis of the data from URIROX-2, and modifying the requirements for filing for accelerated approval of the initial reloxaliase BLA.
- 13 Nov 2019 According to an Allena Pharmaceuticals media release, company plans to file a Biologics License Application (BLA) with the FDA for reloxaliase using the accelerated approval regulatory pathway based on the URIROX-1 results and 24-week biomarker data from the ongoing URIROX-2 trial,
- 13 Nov 2019 According to an Allena Pharmaceuticals media release, topline data expected in the second half of 2021.