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See RELiZORB real-world results #

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RELiZORB (iMMOBILIZED LIPASE) CARTRIDGE

Proven Across Multiple Studies

RELiZORB was shown to normalize* the absorption of fatty acids in pivotal trials1,2

Real-world Use in Neonates and Infants: A Retrospective Evaluation

Significant improvements in weight z-scores and percentiles observed as early as 3 months following initiation of RELiZORB1

This study was a retrospective evaluation of the real-world use of RELiZORB with enteral feeding among 57 neonates and infants aged <1 year at treatment initiation.† The primary efficacy measure was the change from baseline in World Health Organization (WHO) weight z-score at 12 months.1,‡

The intent-to-treat (ITT) population consisted of 96 patients who initiated RELiZORB at >60 centers in the US between 2020 and 2024.1

Out of 96 patients, 10 discontinued RELiZORB use and 57 had weight assessments at baseline and 3, 6, 9, or 12 months (efficacy population).1,§

The demographics and baseline characteristics for the ITT population were comparable to those for the population used to evaluate efficacy.1

Of the 57 patients who used RELiZORB with enteral nutrition1:

  • 4 patients were on human milk
  • 4 patients were on fortified human milk
  • 49 patients were on formula only

For neonates and infants, use of RELiZORB with enteral feeding regimens demonstrated1,§:

  • Statistically significant increases in weight z-scores and percentiles from baseline (initiation of RELiZORB) to 12 months compared to age- and sex-matched reference standards
  • Improvement as early as 3 months

Mean change in weight z-score1,||

Chart depicting an increase in weight z-score change over 12 months

Mean change in weight percentile1,||

Real-world evidence (RWE) offer valuable insights into the safety and effectiveness of a product in a real-world clinical setting. The RWE analyses presented here were conducted using validated methodologies to minimize confounding, control biases, and ensure data integrity. RWE is observational by nature and can only demonstrate association, not causation. Findings derived from RWE should be evaluated alongside all other available clinical trials and data.

No new safety concerns were identified among patients under 1 year of age who initiated RELiZORB.1

SEM=standard error of mean.

*Use of RELiZORB was shown to normalize concentrations to levels consistent with a reference range based on healthy subjects as shown in the literature.2,3
†Data extracted from Alcresta’s insurance claims database examined RELiZORB use between January 2020 and July 2024 at more than 60 centers in the United States.1
‡The ITT population corrected gestation age, weight, and weight z-score mean (min, max) at the time of RELiZORB initiation was 5 months (-2.2, 11.9), 5.36 kg (1.63, 10.93), and -2.23 (-6.71, 1.39).1
§Of the 96 ITT patients, 10 discontinued RELiZORB use (6 for parent/clinician decision, 1 for “lack of efficacy,” and 3 for “reason not provided/other”), yielding a 10% rate of discontinuation for potential intolerance.1
||Mean (SEM) change in baseline-adjusted weight with RELiZORB use. The baseline level prior to RELiZORB start is subtracted for each treatment period, so that each point on the graph represents the change from baseline. Number of patients at baseline was 57, at 3 months was 47, at 6 and 9 months was 36, and at 12 months was 30. Statistically significant changes from baseline (one-sample two-sided t-test P<0.05) are indicated with a paragraph mark (¶).1

Real-world Data in CF: A Retrospective Evaluation

Use of RELiZORB demonstrated long-term clinical growth improvements in people with pancreatic insufficiency due to CF4

This study was a retrospective evaluation of real-world data that was conducted to evaluate the effectiveness of RELiZORB on nutritional status in patients with cystic fibrosis (CF).4

In this review, 100 patients with CF aged 0-45 years who used RELiZORB from 2018-2019 were evaluated. Of these patients, 93 patients aged 2 to 18 years had growth assessments at baseline and 12 months of use.* For these patients, pancreatic enzyme replacement therapy (PERT) use for oral meals and snacks was unchanged.4

Use of RELiZORB demonstrated4:

  • Statistically significant increases in overall weight z-scores at 6 and 12 months following the initiation of RELiZORB, and in height z-scores at 6 months

Change from baseline at 6 and 12 months following initiation of RELiZORB4

Chart depicting height and weight z-scores at 0, 6 and 12 months.

Graph was generated by Alcresta based on Sathe MN. JPGN. 2021.

Use of RELiZORB also demonstrated statistically significant greater improvements in height and weight z-scores from 0 to 6 months compared with a historical cohort (CFFPR-2014†) using PERT with enteral nutrition4

Real-world evidence (RWE) offer valuable insights into the safety and effectiveness of a product in a real-world clinical setting. The RWE analyses presented here were conducted using validated methodologies to minimize confounding, control biases, and ensure data integrity. RWE is observational by nature and can only demonstrate association, not causation. Findings derived from RWE should be evaluated alongside all other available clinical trials and data.

BMI=body mass index; LS=least-square.

*Weight, height, and BMI were normalized to age- and sex-specific z-scores and percentiles of healthy individuals 0 to 24 months of age using the WHO Child Growth Standards and for those 2 to 20 years of age using data from the Centers for Disease Control and Prevention growth charts.4
†Historical cohort data obtained from the Cystic Fibrosis Foundation Patient Registry during the 2014 calendar year (CFFPR-2014) as this data does not include the use of RELiZORB. To be included, patients had to have at least 2 measurements of height and weight at least 6 months apart and not be receiving treatment with ivacaftor.4

Clinical Data in CF

497 Study: A double-blind, placebo-controlled study with a crossover treatment period and a follow-up safety period that were used to measure endpoints1,2

497 study†: A double-blind, placebo-controlled crossover treatment period with a follow-up safety period was used to evaluate safety, tolerability, and fat absorption with RELiZORB in patients with exocrine pancreatic insufficiency (EPI) due to CF.1

View study design

Changes in plasma concentrations of DHA and EPA1

DHA and EPA were used as measures in the studies as they are strongly correlated with overall fat absorption

DHA and EPA were used as measures in the studies as they are strongly correlated with overall fat absorption.

2.8-fold overall increase in total DHA and EPA vs placebo (AUC0-24h; P<0.001)2

GI Events1

GI events are expressed as: number of events (number of patients reporting events)

Gastrointestinal (GI) events are expressed as number of events (number of patients reporting events).

57% reduction in the incidence of diarrhea from Period A to Period C2,†

RELiZORB demonstrated2:

  • An overall decrease in the frequency of GI events in Period C compared with Period A among 33 pediatric and adult patients with CF†
  • Reduced use of PERT during Period C of the trial, with 42% (n=14) of patients who used RELiZORB stopping PERT despite protocol instructions to maintain their usual treatment practice†

DHA=docosahexaenoic acid; EPA=eicosapentaenoic acid.

*Use of RELiZORB was shown to normalize concentrations to levels consistent with a reference range based on healthy subjects as shown in the literature.2,3
†497 Study consisted of 3 distinct periods. Period A lasted 7 days and was meant to establish a baseline while patients maintained their standard PERT dosing along with overnight tube feeding. Period B lasted 11 days (including a 7-day washout period before crossover) and evaluated the effect of RELiZORB use on fat absorption via DHA and EPA plasma measures. Period C lasted 7 days and evaluated the safety and tolerability of RELiZORB by comparing outcomes with Period A (baseline).1

Clinical Data in CF

498 ASSURE Study: Sustained use of RELiZORB normalizes* RBC fatty acid status in people with CF3

498 ASSURE Study: A 90-day, multicenter, open-label study, in which RELiZORB was used with overnight tube feeding, that evaluated the safety, tolerability, and improvement in fatty acid status in red blood cell (RBC) membranes in patients with EPI due to CF.3

View study design

Changes in erythrocyte membrane fatty acid composition (%) for Omega-3 index3

  • Statistically significant increases observed at Days 30, 60, and 90 (P<0.001 for each)
Statistically significant increases observed at Days 30, 60, and 90

2.1-fold increase in RBC uptake of DHA and EPA relative to total fatty acid composition in erythrocyte membranes1,3

Sustained use of
RELiZORB in 498 Study3

  • No reported incidences of diarrhea at Day 90
  • Overall, the number of participants reporting GI symptoms decreased from Day 30 to Day 90
  • No participants discontinued RELiZORB due to an adverse event

61% of participants demonstrated improvement in weight percentiles.3,‡

With sustained use of RELiZORB:

All exploratory efficacy outcomes, including serum levels of fat-soluble vitamins A, D, and E in plasma total protein, prealbumin, albumin, and transferrin, were within normal ranges at study entry and remained so throughout the 90-day study treatment period.3

*Use of RELiZORB was shown to normalize concentrations to levels consistent with a reference range based on healthy subjects as shown in the literature.2,3
†P<0.001 for difference from baseline to Day 30, Day 60, and Day 90.3
‡Overall, weight and BMI z-scores and percentiles were not significantly different from baseline to Day 90. However, 20/33 (61%) patients had improvement in weight z-scores and percentiles in the ITT population.3

Preclinical Studies in EPI Porcine Models

In preclinical porcine models of EPI, RELiZORB improved absorption of fats and fat-soluble vitamins vs enteral nutrition alone1

Single-feed study1,*

Evaluated tolerability and fat absorption with use of RELiZORB during a single tube feeding.

Multi-feed study1,†

Evaluated tolerability and fat absorption with use of RELiZORB following 12 consecutive nightly tube feedings.

DHA & EPA plasma concentrations following use of RELiZORB during a single tube feeding1,*

RELiZORB demonstrated an increase in fat absorption, an increase in plasma levels, and higher plasma levels of fat-soluble vitamins D and E

The clinical significance of these findings has not been determined.1

RELiZORB demonstrated1:

  • An increase in fat absorption and overall caloric intake*,†
  • An increase in plasma levels of omega-3 fatty acids DHA and EPA (p<0.05) compared with animals receiving enteral nutrition not administered through RELiZORB*,†
  • Higher plasma levels of fat-soluble vitamins D and E compared with animals receiving enteral nutrition not administered through RELiZORB†
*Study conducted in a porcine model over 24 hours measured results of a single tube feeding (500 mL; 4 hours, 120 mL/hr) administered through RELiZORB compared to an identical tube feeding that was not administered through RELiZORB.1
†Parallel group study conducted in a porcine model measured results of nightly tube feedings (750 kcal) administered over 12 consecutive days with (n=6) and without (n=5) use of RELiZORB.1

Preclinical Studies in Short Bowel Syndrome (SBS) Porcine Models

Improved nutrient absorption and intestinal adaptation in a preclinical model of SBS1

Continuous study1,*

Evaluated RELiZORB for improvement in fat and nutrient absorption with continuous tube feedings.

Bolus study1,†

Evaluated use of RELiZORB in conjunction with bolus tube feedings in weaning parenteral nutrition (PN).

The decrease in PN calories coincided with an increase in enteral nutrition advancement5,†

The decrease in PN calories coincided with an increase in enteral nutrition (EN) advancement

The clinical significance of these findings has not been determined.1

RELiZORB demonstrated:

  • Enhanced nutrient absorption and similar coefficient of fat absorption (CFA) compared to unresected control group5,6,*,‡
  • A higher average enteral nutrition advancement (66% vs 47% increase in enteral nutrition calories, P<0.0001) compared to control animals receiving enteral nutrition not administered through RELiZORB5,†
  • A 19% greater reduction in PN calories (95% CI: 15%-24%, P<0.0001) compared with control animals receiving enteral nutrition not administered through RELiZORB5,†
  • A significant increase in intestinal length (19.5% vs 0.7%, P=0.03) compared with control animals receiving enteral nutrition not administered through RELiZORB5,†,§

EN=enteral nutrition.

*Parallel study with 3 groups: no intestinal resection (n=5), 75% resection (n=5), and 75% resection plus RELiZORB (n=5). After recovery, the animals were treated for 14 days. Piglets received 60% of calories from continuous enteral nutrition and 40% from chow.1
†Parallel study conducted in a porcine model consisting of 2 groups: 75% intestinal resection (n=6) and 75% resection plus RELiZORB (n=5). PN was initiated post-operatively and was decreased as enteral nutrition was advanced. Enteral nutrition was delivered daily via 6 bolus feeds with or without RELiZORB for 14 days.1
‡No statistically significant difference in CFA between resected animals receiving RELiZORB and unresected animals in the control group (87.1% vs 95.2%, p=0.19).1
§In the preclinical study, intestinal length increased on average by 68.4 ± 19.1 cm (19.5 ± 5.5%) compared with 0.8 ± 18.3 cm (0.7 ± 5.2%) in the control group (P=0.03).5
Photo of Caleb receiving enteral nutrition via syringe using RELiZORB while spending time with his parents.

Caleb, a child who tube feeds with RELiZORB, and his parents, Kayleigh and Jimmy

See how patients use RELiZORB to support their tube feeding

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References: 1. RELiZORB. Instructions for use. Alcresta Therapeutics, Inc; 2025. 2. Freedman S, Orenstein D, Black P, et al. Increased fat absorption from enteral formula through an in-line digestive cartridge in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2017;65(1):97-101. doi:10.1097/MPG.0000000000001617 3. 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;67(4):527-532. doi:10.1097/MPG.0000000000002110 4. Sathe MN, Patel D, Stone A, First E. Evaluation of the effectiveness of in-line immobilized lipase cartridge in enterally fed patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2021;72(1):18-23. doi:10.1097/MPG.0000000000002984 5. Tsikis ST, Fligor SC, Hirsch TI, et al. A digestive cartridge reduces parenteral nutrition dependence and increases bowel growth in a piglet short bowel model. Ann Surg. 2023;278(4):e876-e884. doi:10.1097/SLA.0000000000005839 6. 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. Clin Nutr. 2022;41(5):1093-1101. doi:10.1016/j.clnu.2022.03.026

RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding.

Warnings
  • RELiZORB is for use with enteral tube feeding only.
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RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding.

Warnings
  • RELiZORB is for use with enteral tube feeding only.
  • RELiZORB should not be connected to any intravenous (IV) line, setup, or system.
  • Medications should not be administered through the RELiZORB cartridge. Do not add medications to the enteral nutrition or tubing before RELiZORB. The passage of medications through RELiZORB may adversely affect the medications or the ability of RELiZORB to hydrolyze fats.
  • Fibrosing Colonopathy - Fibrosing colonopathy is a rare, serious adverse reaction associated with high-dose use of pancreatic enzyme replacement therapy in the treatment of patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. RELiZORB contains lipase enzyme that is not from a porcine source. The lipase is bound to the beads, and this lipase-bead complex (iLipase) is retained within the RELiZORB cartridge. Continue to follow your physician’s guidance and porcine pancreatic enzyme labeling regarding porcine pancreatic enzyme use when used in conjunction with RELiZORB.
Cautions and Precautions
  • Do not re-use RELiZORB. RELiZORB is a single-use product. Re-use may result in contamination of the product. If re-used, RELiZORB may not effectively hydrolyze fats.
  • Do not break, alter, or place excess pressure on any part of RELiZORB. Any compromise of the structural integrity of RELiZORB may lead to improper connection to enteral feeding supplies, leakage or risk of contamination.
  • Do not use RELiZORB after the date marked on the pouch.
  • Enteral nutrition administered through RELiZORB is for immediate consumption through an enteral feeding tube. RELiZORB should not be used to process enteral nutrition for later use. This has not been tested and may result in safety issues.
  • RELiZORB is designed for use with enteral feeding pump systems with low flow/no flow alarms and enteral syringes for manual bolus by syringe (push or gravity). A detailed listing of enteral nutrition, pumps, and enteral feeding supplies compatible with RELiZORB can be found at www.relizorbhcp.com/compatibility.
  • Patients less than 1 year old may be particularly vulnerable to unplanned interruptions of feeding.
  • Do not use blenderized formulas with RELiZORB. A detailed listing of enteral nutrition compatible with RELiZORB can be found at www.relizorbhcp.com/compatibility.
  • Powdered formulas should be mixed periodically during feedings.
  • Do not use excessive force on the plunger when using RELiZORB with bolus syringe feeding method.
  • Do not rush bolus feeds. Follow guidance from your healthcare professional on how long it should take you to complete your tube feeding. Ensure all inlet and outlet connectors on RELiZORB and enteral feeding supplies are clean and dry prior to making connections.
  • In order to ensure product performance, store RELiZORB in its pouch either refrigerated or at room temperature (2°C to 27°C; 36°F to 80°F).
  • RELiZORB is indicated for use with enteral feeding only; patients should follow physician’s guidance for pancreatic enzyme replacement therapy (PERT) use for meals and snacks. Patients and patient caregivers should follow physician’s guidance regarding the need for pancreatic enzyme replacement therapy (PERT) during enteral feeding.

Review full product information for RELiZORB in the Instructions for Use.