Benzinga | Jul 12, 2021 11:07AM EDT

Allena Revises Interim Reloxaliase Analysis Targeted Now For Q1 2022; ALLN-346 Phase 2 Data On Track For End Of 2021

* Allena Pharmaceuticals Inc (NASDAQ:ALNA) provided progress updates on its ALLN-346 and reloxaliase (ALLN-177) clinical programs.

* ALLN-346 is an enzyme therapy for hyperuricemia and gout, a metabolic disorder characterized by high systemic levels of uric acid. The Company recently completed a Phase 1b multiple ascending dose study. ALLN-346 was well tolerated with no evidence of systemic absorption, and no significant safety signals and serious adverse events were reported. As previously reported, the Company will initiate two Phase 2a studies to obtain initial bioactivity data and additional safety data for ALLN-346 in 3Q of 2021. Initial results from the Phase 2a program are expected in 4Q of 2021.

* Reloxaliase is an enzyme therapy for enteric hyperoxaluria, a metabolic disorder characterized by high urinary oxalate levels. The Company is currently studying reloxaliase in the second (URIROX-2) of two Phase 3 trials in its URIROX program. As part of the URIROX-2 adaptive design, the Company had previously planned to conduct the first interim analysis in the 2Q or 3Q of 2022. But, given the adverse impact of the COVID-19 pandemic on enrollment, the Company now plans to conduct the first interim analysis in 1Q of 2022. The Company estimates that this revised interim analysis would include UOx data during weeks 1-4 for approximately 80 patients compared with 130 as expected earlier, but would not include sufficient data to evaluate UOx levels during weeks 16-24 or the blinding rate of kidney stone events, as previously planned.

* Price Action: ALNA shares are down 0.01% at $1.22 during the market session on the last check Monday.