NEWTON, Mass., Oct. 28, 2016 /PRNewswire/ -- Alcresta Therapeutics, Inc. (Alcresta), today announced data from the landmark clinical study of RELiZORB, a novel in-line digestive enzyme cartridge designed specifically for use by patients receiving enteral tube feeding who have trouble breaking down and absorbing fats. These results were presented at the 30th Annual Meeting of the North American Cystic Fibrosis Conference (NACFC) in Orlando, Florida.
This study was conducted in pediatric and adult patients with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI) receiving enteral feeding. The absorption of fat was calculated by assessing changes in plasma concentrations over 24 hours of physiologically relevant long-chain polyunsaturated fatty acids (LCPUFAs), such as omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). DHA and EPA are not only sources of energy, but are also essential components of cell membranes, and are integral in maintaining normal development and overall health.
RELiZORB use, compared with administration through placebo, resulted in a statistically significant 2.8 fold improvement (p<0.001) in total DHA and EPA absorption. The study also found that RELiZORB use during the administration of enteral nutrition across both pediatric and adult patients with CF and EPI was found to be safe and well tolerated. There was a decrease in the frequency and severity of GI symptoms, particularly stool-related symptoms, associated with fat malabsorption. Importantly, more patients had a preservation of appetite and were able to eat breakfast.
"We are very pleased and excited about the results of this landmark study. RELiZORB is the only product that is FDA cleared for patients using enteral nutrition and who have fat malabsorption, and therefore addresses a critical unmet medical need," said Daniel Tassé, Chief Executive Officer of Alcresta Therapeutics.
About Study 497
The safety and efficacy of RELiZORB was assessed in a multicenter, prospective, randomized, double-blind, cross-over study, conducted in 33 patients with EPI due to CF. Patients enrolled in the study ranged from 5 to 34 years of age, with a mean age of 14.5 years and had received enteral nutrition for an average of 6.6 years.
Changes in fatty acid plasma concentrations of physiologically relevant LCPUFA omega-3 fats such as DHA and EPA were assessed over 24 hours, reflecting the uptake of fat in enteral formula as a result of using RELiZORB with enteral feeding.
Results of this study indicate that RELiZORB use was safe and well tolerated with a lower frequency and severity of gastrointestinal symptoms as compared to current treatment. RELiZORB use with enteral formula also resulted in a 2.8 fold statistically significant (p<0.001) increase in DHA and EPA fatty acids. Absorption increased regardless of age. RELiZORB use was also associated with a greater preservation of appetite as compared to current treatment practice.
About Fat Malabsorption
Fat malabsorption is most common in individuals who cannot produce adequate amounts of digestive enzymes because of compromised pancreatic function. Most patients with EPI, such as those with CF, pancreatitis, and pancreatic cancer therefore do not produce pancreatic lipase necessary for fat hydrolysis. In certain people, changes in gastric, duodenal, liver, and pancreatic physiology can also dramatically impact malabsorption of critical nutrients, and in particular fat absorption. In these individuals, incomplete hydrolysis (break down) of fats from enteral tube feeding can lead to decreased caloric intake, reduced digestion of essential fats, in particular omega-3 LCPUFAs, deficiencies of fat-soluble vitamins, and increased gastrointestinal symptoms. These negative outcomes can significantly impact quality of life and nutritional status, and can adversely affect a person's ability to maintain or gain weight and absorb necessary nutrients.
Omega-3 fatty acids such DHA and EPA are structural components of membranes and also biological mediators involved in the regulation of various physiological functions. Proper tissue levels of LCPUFAs, such as DHA and EPA, have been linked to optimal brain and vision development, cognition improvement, improved immunity and cardiac health. LCPUFAs, and omega-3 fatty acids DHA and EPA in particular, have been shown to have important anti-inflammatory properties by suppressing inflammatory cytokines. Importantly, people with fat malabsorption, including patients with CF, have been shown to be deficient in DHA and EPA.
A decrease in pancreatic output or change to gastrointestinal physiology results in malabsorption of fats. People with fat malabsorption are at risk for decreased caloric intake, deficiencies in fatty acids, and developing gastrointestinal symptoms associated with fat malabsorption that in turn may diminish appetite and oral intake of nutrients. To improve caloric intake, avoid malnutrition, and reduce fatty acid deficiency, individuals with compromised pancreatic lipase output and fat malabsorption utilize enteral nutrition as a supplement to daily dietary intake.
RELiZORB is a first-of-its kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is designed for use by patients receiving 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 LCPUFAs, such as DHA, EPA, and arachidonic acid, 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 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.
Chief Executive Officer
Alcresta Therapeutics, Inc.
RELiZORB and iLipase are trademarks of Alcresta Therapeutics, Inc. All rights reserved 2016
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Last updated on: 30/10/2016
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