NEWTON, MA, November 11, 2020 — Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel, enzyme-based products, today announced the publication of a 12-month observational study in Journal of Pediatric Gastroenterology & Nutrition that evaluated the effectiveness of long-term RELiZORB® (iMMOBILIZED LIPASE) Cartridge use in enterally fed patients with cystic fibrosis. RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. Real-world data from this study add to the body of clinical evidence that support the use of RELiZORB in enterally fed patients at risk for fat malabsorption.
A 12-month observational study examined the effectiveness of RELiZORB in real-world patients use by a cohort of enterally fed patients with cystic fibrosis.
At just six months of RELiZORB use, patients in their active growth years demonstrated significant improvements in z-scores for both weight (p = 0.002) and height (p < 0.001), from baseline.
After 12-months, patients using RELiZORB demonstrated significant improvement in z-scores for weight (p = 0.017) and height (p = 0.036) compared to baseline. The proportion of patients achieving the Cystic Fibrosis Foundation BMI goal of ≥ 50th percentile increased steadily from 37.1% at baseline to 50.0% at 12 months.
“We are excited by the implications of these real-world data in enterally fed patients with cystic fibrosis who are vulnerable to fat malabsorption. The one-year RELiZORB results are even more impressive when you consider that caloric intake through enteral feeding represents on average just 20% of the overall caloric intake in patients with cystic fibrosis,” said Dan Orlando, CEO of Alcresta.
Eric R. First, M.D, Chief Scientific Officer at Alcresta, added, “This study provides very compelling evidence that RELiZORB demonstrates critical gains in weight and height in patients with cystic fibrosis and should be recognized as standard of care for this patient population. Our hope is that payers will consider this data, along with previous publications, when establishing medical policy and follow Aetna’s and CIGNA’s lead as they both recently determined RELiZORB to be medically necessary for persons with cystic fibrosis on enteral feedings.” http://www.aetna.com/cpb/medical/data/1_99/0061.html.
Access to the abstract and article is available by clicking here: Journal of Pediatric Gastroenterology & Nutrition
RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is indicated for use in pediatric patients (ages five years and above) and adult patients to hydrolyze fats in enteral formula.
RELiZORB was developed using Alcresta Therapeutics’ proprietary enzyme immobilization technology. The digestive enzyme lipase, which is the active ingredient in RELiZORB, is attached to polymeric carriers and together are called iLipase®. As enteral formula passes through the RELiZORB cartridge, it makes contact with the iLipase, allowing for the breakdown of fat in the formula to more absorbable fatty acids and monoglycerides. The iLipase remains in the cartridge and is not 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 (LCPUFAs), such as the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and the omega-6 fatty acid arachidonic acid, all of which are critical for growth and development.
RELiZORB is for use with enteral feeding only; do not connect to intravenous or other medical tubing. Medications should not be administered through RELiZORB. Please see Instructions For Use for full safety information at www.relizorb.com.
About Alcresta Therapeutics, Inc.
Alcresta Therapeutics, Inc. is 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. Alcresta Therapeutics, Inc. currently markets RELiZORB, a first-of-its-kind digestive enzyme cartridge that mimics the function of pancreatic lipase to breakdown fats into more absorbable fatty acids. Based in Massachusetts, Alcresta Therapeutics, Inc. is backed by top-tier venture investors: Athyrium Capital Management, Health Quest Capital, Bessemer Venture Partners, Frazier Healthcare Partners, and Third Rock Ventures. For more information, please visit www.alcresta.com.
RELiZORB, iLipase, the Alcresta capstone, and Alcresta Therapeutics are registered trademarks of Alcresta Therapeutics, Inc. All rights reserved.
Sathe, Meghana N.; Patel, Dhiren‚; Stone, Archie‚; First, Eric. Evaluation of the Effectiveness of In-line Immobilized Lipase Cartridge in Enterally Fed Patients with Cystic Fibrosis, Journal of Pediatric Gastroenterology and Nutrition: November 06, 2020 - Volume Publish Ahead of Print - Issue - doi: 10.1097/MPG.0000000000002984
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