Alcresta Therapeutics Receives 510(K) Clearance For Use Of Relizorb® In Children
RELiZORB, The Only Digestive Enzyme Cartridge for Patients Requiring Supplemental Enteral Nutrition, Now Cleared to Help Children Suffering from Fat Malabsorption
WARREN, N.J.--(BUSINESS WIRE)--Alcresta Therapeutics, Inc., dedicated to developing products designed to address nutritional challenges faced by patients with Cystic Fibrosis, Chronic Pancreatitis, Pancreatic Cancer, Gastric Cancer, and other serious diseases, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its RELiZORB digestive enzyme cartridge for use in pediatric patients suffering from fat malabsorption. RELiZORB was cleared in 2015 for use in patients 18 years and older. This latest clearance will extend the use in children as young as 5 years old.
“FDA clearance for extending the use of RELiZORB into the pediatric population is a significant step forward in addressing the nutritional challenges confronting this critically-ill population.”
Children have a tendency toward reduced metabolic reserves in the form of muscle and fat tissues, when compared to adults. This is due to the increased energy requirements associated with normal growth and development. As a result, children are much more susceptible to the effects of poor nutrition; especially in medical conditions like cystic fibrosis or pancreatitis in which their ability to convert food into energy, as well as into important cellular and tissue building blocks, is compromised 1.
RELiZORB is the only external digestive enzyme therapy designed to mimic the normal pancreatic function of lipase. Pancreatic lipase is a critical enzyme in the digestion of dietary fats and accounts for as much as 90% of fat breakdown by the human body. The inability to absorb fats leads to problems in gaining or maintaining a healthy weight, as well as a deficiency of healthy fats, such as omega-3 fats similar to those found in fish oil and fat-soluble vitamins. These patients are more likely to suffer from gastrointestinal problems such as stomach pain, excess gas, stool-related problems, bloating and nausea. They often have to supplement their oral food intake with enteral tube feedings that are administered overnight. RELiZORB® significantly increases fat absorption by breaking down fats found in enteral nutrition formulas, leading to an increased availability of critical calories and important healthy fats that may otherwise pass through the body unabsorbed.
“This clearance represents a significant milestone for children who suffer from fat malabsorption,” said Daniel Tassé, Chief Executive Officer of Alcresta Therapeutics. “FDA clearance for extending the use of RELiZORB into the pediatric population is a significant step forward in addressing the nutritional challenges confronting this critically-ill population.”
Data from a recent pivotal clinical study, known as the 497 Study, supported this clearance. The findings were recently published in the July issue of the Journal of Pediatric Gastroenterology & Nutrition entitled, Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis.2
“The 497 Study demonstrated the efficacy and safety of RELiZORB use in correcting deficiencies of healthy fats that are often observed in patients receiving enteral nutrition,” said Eric First, M.D., Chief Scientific Officer, Alcresta Therapeutics.
Link to full study Results:
About Alcresta® Therapeutics, Inc.
Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel enzyme-based products designed to treat gastrointestinal disorders and rare diseases. The company uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency, which results in malabsorption common in cystic fibrosis, digestive cancers, premature birth and other serious diseases.
Alcresta Therapeutics’ management team has extensive experience in pharmaceutical, medical device, and nutritional product development. Alcresta’s corporate office is located in Warren, NJ. Alcresta is backed by top-tier venture investors: Athyrium Capital Management, Bessemer Venture Partners, Frazier Healthcare and Third Rock Ventures. More information can be found at www.alcresta.com.
RELiZORB is a registered trademark of Alcresta Therapeutics, Inc. All rights reserved 2017.
1. Skillman HW and Wischmeyer PE. Nutrition therapy in Critically Ill Infants and Children. J Parenter Enteral Nutr. 2008. 32(5):520-34
2. Freedman S. et al. Increased Fat Absorption from Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017. 65(1):97-101
Contacts
Alcresta Therapeutics, Inc.
Daniel Tassé, 877-255-8425
Chief Executive Officer
