Kidney Stones

May 12, 2014

Allena Pharmaceuticals reported results of a phase I trial of ALLN-177 for the treatment of chronic management of hyperoxaluria and kidney stones. The phase I, double-blind, randomized, placebo-controlled crossover study evaluated ALLN-177 compared to placebo in 30 healthy volunteers who were placed on a high oxalate diet and showed a sustained increase in urinary oxalate levels, consistent with clinically meaningful hyperoxaluria. ALLN-177 was shown to significantly and substantially reduce oxalate levels (mg/24 hours) compared with placebo (P= 0.0002). A pre-specified responder analysis also was performed comparing the number of responders for ALLN-177 and placebo and showed that all responders were on ALLN-177 and none on placebo. Responders demonstrated mean reductions of oxalate excretion ranging from 8.3mg/day to more than 40mg/day. ALLN-177 was well-tolerated and no safety signals were noted.