Healthcare Industry News: protein therapeutics
News Release - June 19, 2007
Altus Pharmaceuticals Submits Investigational New Drug Application to Study ALTU-237 for the Treatment for Hyperoxalurias and the Potential Prevention of Kidney Stone FormationCAMBRIDGE, Mass.--(HSMN NewsFeed)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU ) today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for ALTU-237, an orally-delivered crystalline formulation of an oxalate-degrading enzyme. Altus has designed ALTU-237 for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones in individuals with a high risk or history of kidney stones. Following the FDA review period, the Company intends to initiate a Phase I human clinical trial to assess the safety of ALTU-237.
"This IND submission is a significant milestone for Altus Pharmaceuticals. We are pleased to advance ALTU-237, our third clinical program based on the Company's proprietary protein crystallization technology," stated Sheldon Berkle, President and CEO of Altus Pharmaceuticals. "For the majority of patients with hyperoxalurias or recurrent kidney stones there are limited treatment options available. The ALTU-237 pre-clinical data is very encouraging and we are excited about the opportunity to bring our next product into the clinic."
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 pending FDA review, the timing and the initiation by the Company 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 Pharmaceuticals' reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-Q for the fiscal year ended March 31, 2007, as may be updated in its quarterly and current reports. However, Altus Pharmaceuticals undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
Source: Altus Pharmaceuticals
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