Altus Biologics Completes NIH Sponsored Project to Develop Novel Enzymes to Treat Pancreatic Insufficiency
08:47 a.m. Nov 02, 1998 Eastern
CAMBRIDGE, Mass., Nov. 2 /PRNewswire/ -- Altus Biologics Inc. announced today the completion of a Phase I Small Business Innovation Research (SBIR) Grant from National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health, to investigate the development of an orally available lipase enzyme used to treat patients with pancreatic insufficiency, a condition which may result from cystic fibrosis or pancreatitis. TheraCLEC(TM) Lipase, now beginning preclinical development, represents the first application of Altus' Cross-Linked Enzyme Crystal (CLEC(R)) technology to be tested as a potential therapeutic product.
"Research completed under the SBIR grant underscores the potential use of CLEC technology for an orally available therapeutic product for the treatment of alimentary tract and metabolic diseases," commented Peter Lanciano, President of Altus. "TheraCLEC will rely on the proprietary CLEC technology with the objective of stabilizing enzymes and proteins against attack from harsh conditions in the alimentary tract while retaining the bioactivity of the enzyme or protein."
The $100,000 Phase I SBIR grant was used to investigate and optimize TheraCLEC Lipase crystals as carrier-free, highly stabilized protein formulations designed to survive the harsh acidic pH and proteolytic conditions of the digestive tract while retaining the enzyme's native biochemical activity. Since completing the Phase I SBIR grant, Altus has advanced the TheraCLEC Lipase into preclinical development. If successfully developed, TheraCLEC Lipase would represent the first product in a class of novel oral protein delivery products to be commercialized by Altus.
"We are encouraged by the early feasibility research we have conducted on TheraCLEC Lipase crystals," said Dr. Alexey Margolin, Vice President of Science at Altus. "The initial research supports the potential for enhanced safety and efficacy with the CLEC lipase crystals over currently marketed pancrealipase products."
Current pancreatic insufficiency treatments have demonstrated poor efficacy, tolerability and safety profiles and patient compliance is often a problem since patients, who are primarily children, must ingest several grams of tablets per day. The goal in developing TheraCLEC Lipase is to provide advantages over conventional enzyme replacement products including compact oral dosing and enhanced degradation of dietary fats. Moreover, the product has the potential for eliminating safety problems reported in 1991 for some pancrealipase products because the CLEC formulation of pure enzyme used in TheraCLEC Lipase is devoid of any enteric coatings or other excipients, and is designed not to be absorbed from the gastrointestinal tract.
Altus Biologics Inc., a subsidiary of Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), develops and markets proprietary protein stabilization technology. The Company's lead products, CLEC(R) brand catalysts, are crystallized, cross-linked enzymes that are versatile, durable and environmentally benign. Altus develops, manufactures and sells CLEC brand products for use in specialized chemical and pharmaceutical manufacturing, biomedical applications, and in consumer products.
There can be no assurance that the CLEC product will successfully enter or complete clinical trials, or that compounds will receive marketing approval from the U.S. Food and Drug Administration or equivalent regulatory authorities, or that drugs, if any, which receive such approval will be marketed successfully. Investors are also directed to consider other risks and uncertainties discussed in documents filed by Vertex Pharmaceuticals Incorporated with the Securities and Exchange Commission. SOURCE Altus Biologics Inc.
Copyright 1998, PR Newswire
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