- Allena Pharmaceuticals Inc 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.
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