Altus Pharmaceuticals' ALTU-237 Enters Phase I Clinical Trial for the Treatment of Hyperoxalurias and the Potential Prevention of Kidney Stone Formation
Altus Pharmaceuticals Inc. (NASDAQ: ALTU) today announced that it has initiated a Phase I clinical trial of ALTU-237, 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. ALTU-237 has the potential to address these conditions, for which there are limited effective pharmacological treatments.
The ALTU-237 Phase I clinical trial is a single-center, double-blind, placebo-controlled, dose escalating study evaluating the safety and tolerability of ALTU-237 in normal, healthy adults. The study plans to enroll 64 normal, healthy adults that will be randomized into several cohorts. A secondary objective of the trial is to determine the clinical activity of escalating dose levels of ALTU-237, as measured by changes in urinary oxalate levels in normal healthy adults on a controlled, high oxalate diet and to identify a dose of ALTU-237 for future studies.
“This clinical trial is another important step in evaluating the potential of ALTU-237 as a treatment for hyperoxalurias and the prevention of recurrent kidney stones,” stated Sheldon Berkle, President and CEO of Altus Pharmaceuticals. “The broad range of doses should provide valuable information for future trial design. If the Phase I trial results demonstrate that ALTU-237 is safe in humans, we expect to conduct additional clinical trials to investigate the potential activity of ALTU-237 in different hyperoxaluria-related indications.”
About Hyperoxaluria
Hyperoxaluria is a disease characterized by excessively high levels of oxalate in the urine, which can be a precursor to forming kidney stones. Hyperoxaluria can be caused by either excessive absorption of dietary oxalate (enteric hyperoxaluria) or increased endogenous production of oxalate (primary hyperoxaluria). When untreated, primary hyperoxaluria could lead to recurrent kidney stones and could contribute to renal failure. Ultimately, patients suffering from severe primary hyperoxaluria experience calcium deposits in their organs, which, if left untreated, could lead to death.
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