Data from the ASSURE Study of Long-Term Use of RELiZORB® Published in Journal of Pediatric Gastroenterology and Nutrition

WARREN, N.J.--(BUSINESS WIRE)-- Alcresta Therapeutics, Inc., a company dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases, today announced new data published in the Journal of Pediatric Gastroenterology and Nutrition regarding RELiZORB (iMMOBILIZED LIPASE) CARTRIDGE, an in-line digestive enzyme cartridge indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula. Data from the ASSURE study evaluating the long-term safety, tolerability, and improvement of fatty acid status with RELiZORB in patients with cystic fibrosis (CF) show that, in a population known to have deficiencies in critical fatty acids, use of RELiZORB resulted in significant increases of the fatty acids DHA and EPA over 90 days.

“The improvements in these critical long chain polyunsaturated fatty acid levels seen in this longer term trial have major implications not only in growth and weight parameters, but also in potentially attenuating the excessive inflammation that underlies cystic fibrosis,” said Steven Freedman, M.D., Ph.D., Chief, Division of Translational Research at Beth Israel Deaconess Medical Center.

Despite having used oral pancreatic enzyme replacement therapy (PERT) capsules with overnight enteral feedings for an average of 6 years, patients entering the study had low levels of DHA and EPA reflecting a poor nutritional status. During the study, participant DHA and EPA levels normalized, indicating improvement in absorption of fats with the use of RELiZORB.

Key Findings:

• A 2.1-fold increase in red blood cells of DHA and EPA and a 2.3-fold increase in plasma levels
• A 2.2-fold decrease of omega 6:3 ratio, a key marker of inflammation
• Improvements were found across all age groups and were independent of the severity of disease or duration of enteral nutrition
• 61% of participants had improvement in weight percentiles, with similar increases observed in the 5 to 12 year and 13 to 18 year age groups
• All exploratory efficacy outcomes, including serum levels of fat-soluble vitamins A, D, and E in plasma as well as serum protein (total protein, pre-albumin, albumin, and transferrin) levels, were within normal ranges at study entry and remained so throughout the 90-day study treatment period
• Decreased frequency of GI symptoms was observed with sustained RELiZORB use
• Long-term use of RELiZORB was found to be safe and well tolerated, and RELiZORB use was not associated with any unanticipated adverse events

The omega-3 index used in ASSURE provides a measure of DHA and EPA levels in red blood cells and is a reliable estimation of long-chain polyunsaturated fatty acid (LCPUFA) absorption and tissue accretion in patients with cystic fibrosis. This index was first used as a predictor of cardiovascular outcomes and is being applied to studies of patients with cystic fibrosis.

“We’re excited by the findings from ASSURE, which represents the largest prospective study to date in patients with cystic fibrosis receiving enteral formula. These findings, when added to our previously published randomized study evaluating the short-term use of RELiZORB in patients with cystic fibrosis on enteral tube feeding, supplement the growing body of evidence to validate the benefits of RELiZORB,” said Daniel Tassé, Chief Executive Officer, Alcresta Therapeutics, Inc. “We are continuing to invest in the RELiZORB development program in order to generate data as part of our commitment to providing options for patients who require enteral nutrition.”

This is the second study published in the Journal of Pediatric Gastroenterology and Nutrition evaluating RELiZORB in the cystic fibrosis patient population, and the results expand on what was found in the first published study.

About the ASSURE Study

The Absorption and Safety with Sustained Use of RELiZORB Evaluation (ASSURE) study is the largest prospective study to date in patients with cystic fibrosis on enteral formula. The open label study looked at 39 patients, representing approximately 1% of the cystic fibrosis enteral feeding population, who ranged in age from 5 to 33 (mean age, 13.8 years) at 10 US cystic fibrosis treatment centers. The study period was 90 days, following a 7 day run-in period. RELiZORB was administered with overnight enteral formula. PERT was used with oral food intake but not with overnight feeding.

About Alcresta® Therapeutics, Inc.

Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients 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 Alcresta Therapeutics, Inc. management team has extensive experience in pharmaceutical, medical devices, and nutritional product development. The corporate office is based in Warren, New Jersey with additional R&D sites in the Boston, MA area and is backed by top-tier investors: Athyrium Capital Management, Bessemer Venture Partners, HealthQuest Capital, Frazier Healthcare Partners, and Third Rock Ventures. More information can be found at www.alcresta.com.

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