Key RELiZORB® clinical accomplishments


RELiZORB initially received de novo approval based on pre-clinical data. De novo approval was followed by published short and long-term clinical efficacy and safety data that expanded the RELiZORB label to include patients down to 5-years of age.1,2 CMS listed a unique B-Code and KOLs published a consensus statement supporting greater patient access to RELiZORB as standard of care for patients with cystic fibrosis on enteral feeding.

RELiZORB is indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB is for use with enteral feeding only; do not connect to intravenous or other medical tubing. Medications should not be administered through RELiZORB. For more information about RELiZORB, including Instructions for Use and Patient Guide, please visit RELiZORB.com.
 

Review our studies

Enzyme products
designed for
enteral nutrition

Pre-Clinical Animal Studies

The results from animal studies demonstrate that when iLipase® or RELiZORB are used to hydrolyze fats in enteral formulas prior to ingestion, the pre-hydrolyzed formulas are well-tolerated. Observation of study subjects suggests that there is no safety risk resulting from the use of iLipase or RELiZORB to hydrolyze fats in enteral formulas. In addition, these animal studies indicate that use of iLipase or RELiZORB to hydrolyze fats in enteral formula results in increased plasma concentrations of long-chain fatty acids.
 

Human Clinical Studies

RELiZORB is the only clinically-studied and FDA-cleared product addressing fat malabsorption in enteral nutrition. Extensive clinical data supports the benefits and versatility of RELiZORB in cystic fibrosis.

24-Hour Study1
(P<0.001)

Change from Baseline in Total DHA & EPA (µg / mL) Over Time

2.8x overall increase in total DHA and EPA plasma concentrations

68% reduction in the incidence of diarrhea

90-Day Study2
(P<0.001)

RBC DHA + EPA (%) Over Time

2.1x increase of DHA and EPA in red blood cell membranes

0% reported incidence of diarrhea at Day 90

Therapeutic Targets

Alcresta Therapeutics has developed a novel enzyme-based (iLipase) platform to address the challenges of fat malabsorption faced by people living with serious or rare diseases, such as cystic fibrosis, pancreatitis, short bowel syndrome, and other conditions associated with fat malabsorption. Fat malabsorption has devastating consequences and is caused by the impaired secretion of the pancreatic enzyme lipase, usually associated with exocrine pancreatic insufficiency (EPI), or with changes in gastric, duodenal or liver physiology. Lipase enzymes are essential to the hydrolysis and absorption of dietary fats, especially long chain polyunsaturated fats (LCPUFAs). Conditions commonly associated with fat malabsorption include3,4::

  • Cystic fibrosis
  • Acute/chronic pancreatitis
  • Abdominal surgery
  • Short bowel syndrome
  • Neonatal intensive care unit (NICU)
  • Trauma/critical care
  • Pancreatic cancer and other cancers/treatments

Alcresta is uniquely positioned to be the leader in the fat malabsorption market in underserved rare and orphan disease populations. Most of the studies conducted to date have focused on cystic fibrosis and pancreatitis. However, other indications associated with fat malabsorption will continue to be studied.

References:
  1. Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017;65:97-101. https://doi.org/10.1097/mpg.0000000000001617
  2. Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding. J Pediatr Gastroenterol Nutr. 2018 Oct;67(4):527-532. https://doi.org/10.1097/mpg.0000000000002110
  3. MedLinePlus Website. https://medlineplus.gov/ency/article/000299.htm
  4. Haupt ME, Geller DE, Hall JA, Quintana Diez PM. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol. 2017;23(39):7059-7076. https://doi.org/10.3748/wjg.v23.i39.7059