Altus reports positive results from Phase I hyperoxaluria trial

The ALTU-237 Phase I clinical trial was a single-center, double-blind, placebo-controlled, dose escalating study. The primary objective was to evaluate the safety and tolerability of ALTU-237 in healthy adult volunteers. The study enrolled 58 healthy adults that were randomized to receive one of four doses of ALTU-237 (900; 3,600; 10,800 or 18,000 units per day) or placebo.

Trial participants consumed a controlled, high oxalate diet and the effect of ATU-237 was measured by comparing the levels of urinary oxalate before and after the administration of ALTU-237 or placebo.

ALTU-237 is an orally-delivered crystalline formulation of an oxalate-degrading enzyme that is being developed for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones in individuals with a high risk or history of kidney stones.

Georges Gemayel, president and CEO of Altus Pharmaceuticals, said: “In this study ALTU-237 was safe and well-tolerated in humans. Healthy adult volunteers received a high oxalate diet and their urinary oxalate increased to the upper limit of the normal range. The ALTU-237 treatment did not result in a substantial or dose-dependent reduction in urinary oxalate levels.”