Altus Presents Safety and Clinical Activity Results for TheraCLEC at North American Cystic Fibrosis Conference.

Health/Medical Writers

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 22, 2003

Altus(R) Biologics Inc. today announced that TheraCLEC(TM), the Company's novel enzyme replacement therapy, showed a favorable safety and clinical activity profile in a Phase I clinical trial. This multi-center study was conducted in patients with cystic fibrosis who suffer from malabsorption as a result of pancreatic insufficiency. The data indicated that TheraCLEC was well tolerated at all dose levels and also showed clinical activity for fat and protein absorption with as little as one capsule per meal. The data was presented at the 17th Annual North American Cystic Fibrosis Conference held October 16-19, 2003 in Anaheim, California. TheraCLEC is the first in a new class of oral enzyme replacement therapies being developed by Altus and is intended to treat malabsorption as a result of pancreatic insufficiency, a condition that affects most people with cystic fibrosis as well as people with chronic pancreatitis.

Drucy Borowitz, M.D, of The Women and Children's Hospital of Buffalo, NY and the principal investigator for the Phase I trial noted, "TheraCLEC represents a new class of orally delivered enzyme replacement therapies that is expected to provide improved stability and potency. The completion of this study and the information learned represents an important step for patients in the evolution of improving how we treat exocrine pancreatic insufficiency in patients with cystic fibrosis."

Key Study Findings

The multi-center study looked at the safety and clinical activity of TheraCLEC in cystic fibrosis patients with malabsorption as a result of pancreatic insufficiency. The study demonstrated that TheraCLEC, in repeated doses, showed a favorable safety and tolerability profile across a range of doses in patients with cystic fibrosis. Patients in the trial also showed a significant improvement in both fat and protein absorption, with as little as one capsule per meal. Fat and protein absorption are key markers for growth, nutrition and survival in patients with cystic fibrosis.

"We are very encouraged by the results of this trial and other clinical studies for TheraCLEC," said Christopher Stevens, M.D., Director, Medical Affairs and Clinical Research at Altus. Dr. Stevens noted, "TheraCLEC, in repeated doses, was well tolerated and clinically active. We believe this novel enzyme replacement therapy will make a real difference in the lives of patients and provide a major improvement in treating pancreatic insufficiency. The data from this study, one of the most comprehensive trials of its type ever conducted for pancreatic insufficiency, will serve as the foundation for our clinical development program which includes plans for a large multi-center Phase II trial that is scheduled to begin shortly."

About TheraCLEC

TheraCLEC is the first in a new class of oral enzyme replacement therapies from Altus and is intended to treat malabsorption as a result of exocrine pancreatic insufficiency, a condition that affects most people with cystic fibrosis as well as patients with chronic pancreatitis. In each of these diseases, a deficiency of pancreatic enzymes causes poor absorption of essential nutrients, which often leads to malnutrition, impaired growth and poor survival. TheraCLEC is intended to replace missing digestive enzymes to promote and maintain proper digestion and growth in affected patients.

TheraCLEC is the first in a portfolio of products under development applying Altus' technology and expertise to orally delivered protein therapies to treat gastrointestinal and metabolic diseases. Protein therapeutics delivered as oral lumenal therapies offer distinct advantages over systemically delivered proteins because they are directly and more readily delivered to the site of action, which may lead to a significant therapeutic effect, and an improved safety profile.

About Cystic Fibrosis

Cystic fibrosis (CF) is a life-threatening disease in which mucus secretions become abnormally thick, hampering the normal functioning of the digestive, respiratory, hepatic and reproductive systems. As a result, malnutrition can occur and normal growth may be hindered. CF affects nearly 30,000 people in the United States and 35,000 people in Europe. In the US, nearly 90 percent of people with CF are afflicted with pancreatic insufficiency and have an average life expectancy in the early 30's, while CF patients without pancreatic insufficiency have a life expectancy of about 50 years.

About Altus

Altus is a pharmaceutical company that uses its proprietary protein crystallization technology to develop innovative, orally delivered enzyme replacement therapies to treat a number of significant unmet medical needs in the areas of gastrointestinal and metabolic diseases. Altus' protein crystallization technology, known as Crystalomics(TM), enables the rapid commercialization of high-value orally delivered protein-based products by creating highly stable and potent protein therapeutics. The technology enables oral delivery of the protein to the gastrointestinal tract to provide a localized or topical effect within the gastrointestinal lumen. These products are novel therapies that are designed to be safe, effective and convenient for patients. Through its product portfolio, the Company's vision is to be the worldwide leader in the rapid and efficient development of valuable oral enzyme replacement therapies for the treatment of gastrointestinal and metabolic diseases. The Company has a series of products in various stages of research and development, all leveraging the Crystalomics technology. Altus has numerous development partners and is constantly evaluating the opportunity to expand its product development efforts through partnering opportunities.

For more information about TheraCLEC and for upcoming clinical trials you can contact the Altus Medical Product Information Department at 1(617) 299-2900.