Altus Pharmaceuticalsâ€™ ALTU-237 Enters Phase I Clinical Trial for the Treatment of Hyperoxalurias and the Potential Prevention of Kidney Stone Formation
- Category: Proteins and Peptides
- Published on Wednesday, 15 August 2007 04:00
- Hits: 3561
CAMBRIDGE, MA, USA | August 14, 2007 | 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.”
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.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Cambridge, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The company is listed on the Nasdaq Global Market under the symbol ALTU.
Safe Harbor Statement
Certain statements in this news release concerning Altus Pharmaceuticals’ business are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus Pharmaceuticals might make or by known or unknown risks and uncertainties, including, but not limited to the enrollment of subjects and the timing of the ALTU-237 Phase I clinical trial, the development risks of an early stage clinical program and the uncertainty of results in future clinical trials evaluating efficacy as well as safety. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus’ reports to the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended June 30, 2007. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
SOURCE: Altus Pharmaceuticals Inc.