Alcresta Therapeutics Announces Preclinical Data Showing ALC-078 Cartridge Use in SBS Model Associated with Reduced Dependence on Parenteral Nutrition

Results published in Annals of Surgery highlight potential applications of Alcresta's ALC-078 cartridge in short bowel syndrome nutrition management

WALTHAM, Mass., March 16, 2023 /PRNewswire/ -- 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 treatment with ALC-078 was associated with reduced dependence on parenteral nutrition (PN), higher enteral nutrition (EN) advancement, and an increase in intestinal length, an indicator of intestinal adaptation.

"ALC-078 is being developed as a next-generation iteration of RELiZORB^® to meet the nutritional needs for enterally fed patients living with rare diseases. The expanded utility of ALC-078 includes compatibility with a broader range of enteral formulas and bolus feeding, a common enteral nutrition approach for individuals with short bowel syndrome, potentially allowing for more patients to benefit from the device," said Greta Loring, PhD, Vice President of Research and New Product Development at Alcresta.

Alcresta previously demonstrated that use of ALC-078 increases enteral fat and fat-soluble vitamin absorption in a porcine model of SBS comparing continuously enterally fed piglets treated with ALC-078 versus piglets not treated with ALC-078.¹ Based on these results, it was hypothesized that use of ALC-078 will reduce PN dependence in this bowel resection model of SBS. In individuals with SBS, PN is typically necessary following intestinal resection to supply daily nutritional requirements.² However, long-term use of PN is associated with significant morbidity and mortality.³ Advancing EN autonomy and freedom from PN would represent a significant advantage for SBS patients.⁴ This study was performed to evaluate the safety and efficacy of ALC-078 when used in conjunction with bolus enteral feeding in weaning PN.

In the 14-day study, animals that received bolus enteral nutrition administered through the ALC-078 cartridge demonstrated advancements in weaning from PN and physiological outcomes compared with piglets that did not receive ALC-078. These outcomes include:

• greater reduction in PN calories and increased advancement in EN;
• increased intestinal crypt cell proliferation;
• higher plasma GLP-2, a critical factor in intestinal rehabilitation and growth⁵; and,
• increased intestinal length.

Use of ALC-078 showed no evidence of increased frequency of adverse events compared to piglets not treated with ALC-078.

"The results of this new study confirm our hypothesis that the use of EN administered through ALC-078 can improve weaning from PN and advancement to EN in a porcine SBS model, highlighting the potential use of ALC-078 to address unmet nutritional needs in SBS patients," stated David Recker, M.D., Chief Medical Officer at Alcresta. He added, "Alcresta is excited to continue its collaboration with the pediatric surgical research team at Boston Children's Hospital led by Mark Puder, M.D., PhD for the development of ALC-078, as well as the ongoing RELiZORB clinical trials, which are currently enrolling at Boston Children's Hospital for patients with SBS."

For access to the publication, visit: Tsikis, ST, et al., A Digestive Cartridge Reduces Parenteral Nutrition Dependence and Increases Bowel Growth in a Piglet Short Bowel Syndrome. Ann. Surg. 2023.

For more information about RELiZORB clinical trials now enrolling patients, visit ClinicalTrials.gov NCT03530852 and NCT05635747.

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 intravenous 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 Therapeutics, Inc. is backed by top-tier investors: Athyrium Capital Management, Bessemer Venture Partners, HealthQuest Capital, and Frazier Healthcare Partners. More information can be found at www.alcresta.com.

Internal Media Contact:

Corey Starke
Alcresta Therapeutics, Inc.
[email protected] 
617-431-3600

References:

1. Tsikis ST, Fligor SC, Secor JD, et al. An in-line digestive cartridge increases enteral fat and vitamin absorption in a porcine model of short bowel syndrome. Clinical Nutrition. 2022;41(5):1093-1101. doi:10.1016/j.clnu.2022.03.026
2. Short bowel syndrome - symptoms, causes, treatment: Nord. National Organization for Rare Disorders. https://rarediseases.org/rare-diseases/short-bowel-syndrome/#therapies. Published January 12, 2023. Accessed March 13, 2023.
3. DeLegge M, Alsolaiman MM, Barbour E, Bassas S, Siddiqi MF, Moore NM. Short bowel syndrome: Parenteral nutrition versus intestinal transplantation. where are we today? Digestive Diseases and Sciences. 2007;52(4):876-892. doi:10.1007/s10620-006-9416-6
4. Channabasappa N, Girouard S, Nguyen V, Piper H. Enteral nutrition in pediatric short–bowel syndrome. Nutrition in Clinical Practice. 2020;35(5):848-854. doi:10.1002/ncp.10565
5. Harpain F, Schlager L, Hütterer E, et al. Teduglutide in short bowel syndrome patients: A way back to normal life? Journal of Parenteral and Enteral Nutrition. 2021;46(2):300-309. doi:10.1002/jpen.2272

SOURCE Alcresta Therapeutics, Inc.