Thinly traded nano cap Allena Pharmaceuticals (ALNA -46.7%) is getting roughed up on a 22x surge in volume in reaction to results from two clinical trials evaluating lead candidate reloxaliase (ALLN-177) in patients with a fat malabsorption disorder called enteric hyperoxaluria (EH), both positive outcomes according to the company.
The Phase 3 URIROX-1 study met the primary endpoint of percent change from baseline in 24-hour urinary oxalate excretion (UOx) during weeks 1-4. Specifically, the mean reduction was 22.6% in treated patients compared to 9.7% for placebo (p=0.004), a separation of 12.9%.
Preliminary data from Study 206, a Phase 2 trial in EH patients with advanced chronic kidney disease (CKD), showed UOx reductions of 29% and 42%, respectively, over weeks 4-12 in two patients with Stage 3 CKD. Significant reductions in plasma oxalate (POx) were also observed (19 – 68%) across eight participants.
Investors appear to be reacting to the lower effect on UOx levels in the late-stage study.
The data analyses are ongoing.
Another Phase 3, URIROX-2, is currently recruiting patients. The estimated completion date is January 2023.
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