Alcresta Therapeutics Announces Preclinical Data Showing ALC-078 Cartridge use in SBS Model was Associated with Improved Fat and Nutrient Absorption
Preclinical data published in Journal of Clinical Nutrition highlight potential applications of ALC-078 cartridge in short bowel syndrome nutrition management.
Newton, MA—April 27, 2022—Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced publication of preclinical data from the company’s development device, ALC-078, in a porcine short bowel syndrome (SBS) model. Results from the study conducted at Boston Children’s Hospital showed that the treatment with ALC-078 was associated with improvements in fat and nutrient absorption.
“ALC-078 is being developed as an iteration of RELiZORB® that could expand the utility of this innovative device for use with a broader range of enteral formulas, including those specific to SBS, while also expanding the potential for use in bolus feeding, which is a common enteral feeding approach in SBS patients who often exceed 1000mL of formula per day,” said Greta Loring, VP of Research and Development at Alcresta.
The study assessed the use of a novel enteral feeding porcine SBS model in addressing a gap in data regarding the management of enterally fed SBS piglets weaned off parenteral nutrition (PN). SBS piglets gain less weight, develop fat malabsorption, and demonstrate a decrease in fat-soluble vitamin concentrations, representing important clinical sequelae in the pediatric and adult SBS populations not previously shown in other preclinical studies. Patients with SBS who are weaned off PN still experience sequelae of the disease (e.g., need for intravenous fluid supplementation and worsening nutritional deficiencies), which further highlights the importance of utilizing porcine SBS models without PN support to encompass the wide clinical spectrum of SBS. The three-arm study compared non-resected normal control, 75% bowel resected, and 75% bowel resected piglets treated with ALC-078.
In the 14-day study, animals that received continuous enteral nutrition administered through the ALC-078 cartridge demonstrated improved fat and nutrient absorption by a variety of measures when compared to resected animals that did not receive ALC-078 over the 14-day study. These outcomes include:
- increased coefficient of fat absorption (CFA), a measure of the percentage of absorbed fat in the diet
- decrease in serum triglyceride concentrations
- improvement in HDL concentration
- improvement in Vitamin D and E concentration
Use of ALC-078 showed no evidence of increased frequency of adverse events compared to the other groups in this model.
Eric R. First, M.D, Chief Scientific Officer at Alcresta stated, “The results from this study confirm the presence of fat malabsorption in SBS by comparing resected piglets to normal controls. In addition, enteral nutrition administered through the ALC-078 cartridge improved nutrient absorption and volume of both the enteral formula and oral feedings.” He added, “Alcresta is excited about the progress being made in the development of ALC-078 and is also very appreciative of the collaboration with the highly skilled pediatric surgical research team, headed up by Mark Puder, M.D., PhD; a world-leading expert in SBS, parenteral and enteral feeding at Boston Children’s Hospital”.
For access to the publication, visit: Tsikis, ST, et al., An in-line digestive cartridge increases enteral fat and vitamin absorption in a porcine model of short bowel syndrome. Clin Nutr 2022:41: 1093-1101.
About Short Bowel Syndrome
Short bowel syndrome (SBS) results from significant intestinal loss due to infection, injury, or physiologic defects, and is characterized by insufficient absorption of nutrients and fluids including hard to absorb fats. Preclinical large animal SBS models typically require i.v. administration, known as parenteral nutrition (PN) support, and thus may not be appropriate for studying interventions to improve intestinal absorption or adaptation.
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. Alcresta currently markets RELiZORB for enterally fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and is developing platform applications for patients with short bowel syndrome (SBS) and prematurely born infants treated in the NICU. Alcresta 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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