Patients with fat malabsorption due to compromised pancreatic function lack the pancreatic enzymes necessary to properly digest and absorb fats from their diet. This has two potential consequences: first, this limits the caloric and vital nutrient intake and the ability of patients to maintain or gain weight; and second, the malabsorption of fats can cause significant gastrointestinal symptoms (e.g., steatorrhea, flatulence, cramps) which may affect patient quality of life and adherence with treatment.
When patients with fat malabsorption, such as those with cystic fibrosis or pancreatic or liver disease, cannot maintain their weight or develop nutritional deficits, they often rely on supplemental nutrition through a gastrostomy tube (or G-tube) to meet their nutritional needs. Until the FDA clearance of RELiZORB in November of 2015, there had been no approved products available to break down or hydrolyze fats in enteral tube feeding formulas.
The launch of RELiZORB will be focused on adults with cystic fibrosis who rely on enteral nutrition. Approximately 90 percent of patients with cystic fibrosis have fat malabsorption, and about 10-15% of patients with cystic fibrosis rely on enteral nutrition in order to meet their nutritional needs.
"The launch of RELiZORB, our flagship enzyme-based product, for use in adult patients with cystic fibrosis who rely on daily enteral feeding to support their medical and nutritional needs marks a hopeful day for patients that suffer from this condition," said Daniel Tassé, Chief Executive Officer of Alcresta Therapeutics.
According to the Cystic Fibrosis Foundation's 2014 Patient Registry Annual Data Report, nutrition status and lung function are related, and improvements in body mass index (BMI) are associated with increased pulmonary function. The correlation between lung function and BMI reinforces the need for individuals to maintain adequate weight gain and absorb critical fatty acids and other nutrients.
In 2013, Cystic Fibrosis Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, issued an award to Alcresta Therapeutics, Inc. to accelerate the development of products to optimize the benefits of enteral feeding in people living with CF.
"The launch of RELiZORB for use in adult patients with cystic fibrosis who receive enteral tube feeding is just the beginning for us as we continue our efforts to bring innovative products to people in need of improved nutritional care," said Robert Gallotto, Co-Founder and President of Alcresta Therapeutics.
RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is designed for use by adults on enteral tube feeding who have trouble breaking down and absorbing fats. RELiZORB was developed using Alcresta Therapeutics' proprietary enzyme immobilization technology. The active ingredient in RELiZORB is the digestive enzyme lipase, attached to polymeric carriers, together called iLipase™.
As the enteral tube feeding formula passes through RELiZORB it makes contact with the iLipase, and the fat in the formula is broken down to its absorbable form (fatty acids and monoglycerides) prior to ingestion. The iLipase remains in the cartridge and does not become part of what is ingested. RELiZORB has been shown to break down more than 90 percent of fats in most enteral feeding tube formulas tested, including the most difficult to break down long-chain polyunsaturated fatty acids, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and arachidonic acid (AA), which are critical for growth and development.
Over time, decreased fat absorption can lead to deficiencies in important fatty acids, such as omega-3 fatty acids. A balanced ratio of omega-3 to omega-6 fatty acids is beneficial in maintaining normal development and overall health.
About Cystic Fibrosis
Cystic fibrosis is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time. In people with CF, a defective gene causes a thick, buildup of mucus in the lungs, pancreas and other organs. In the lungs, the mucus clogs the airways and traps bacteria leading to infections, extensive lung damage and eventually, respiratory failure. In the pancreas, the mucus prevents the release of digestive enzymes that allow the body to break down food and absorb vital nutrients.
About Alcresta Therapeutics, Inc.
Alcresta Therapeutics is a company dedicated to developing and commercializing novel enzyme-based products designed to address challenges faced by people living with 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. The company's lead product, RELiZORB™, is designed to reliably and efficiently deliver the optimal nutritional and caloric benefit from existing enteral tube feeding formulas by improving the breakdown and absorption of fats, in particular long-chain polyunsaturated fatty acids like omega-3 (including DHA, EPA). The importance of long-chain polyunsaturated fatty acids like omega-3 is well documented across the full spectrum of patient care from infants to adults and individuals battling acute conditions or chronic diseases. The company's platform is supported by the Alcresta team's extensive experience in pharmaceutical, medical device, and nutritional product development. Based in Massachusetts, the company is backed by top-tier venture investors like Athyrium Capital Management, Bessemer Venture Partners, Frazier Healthcare and Third Rock Ventures. For more information, please visit www.alcresta.com.
Alcresta Therapeutics, Inc.
RELiZORB and iLipase are trademarks of Alcresta Therapeutics, Inc. All rights reserved 2016.
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SOURCE Alcresta Therapeutics, Inc.