Short-term Study Results (24 hour)1

A multicenter, prospective, randomized, double-blind, placebo-controlled, cross-over study conducted in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). Thirty-four screened patients were enrolled as participants in the study: 1 withdrew after hospitalization for pulmonary exacerbation, 1 withdrew after initially receiving the incorrect formula but re-enrolled; 33 were randomized and completed the study. Patients were ages 5-34 with CF-associated EPI, receiving supplemental enteral nutrition (EN).1

  • Periods A and C: adverse and GI events with up to 1000 mL enteral forumla
  • Period B: assess change in DHA and EPA over 24 h after single 500 mL Impact Peptide 1.5 (32g fat and 2.45g DHA/EPA)

Endpoints

  • Change in fatty acid plasma concentration of DHA and EPA
  • GI symptoms

Over 24 hours: Changes in plasma concentrations of DHA and EPA (omega-3 fatty acids)

This chart shows the clinical results of RELiZORB in terms of the changes in plasma concentrations of DHA and EPA (omega-3 fatty acids).
  • DHA and EPA were used as measures in the study as they are strongly correlated with overall fat absorption3

>50% of Patients Reported a Decrease in the Frequency of Some GI Events1

In the short-term study, overall the frequency of GI events decreased in Period C compared with Period A among 33 pediatric and adult patients with cystic fibrosis

This chart shows the clinical results of RELiZORB in terms of the changes in incidence of diarrhea from Period A to Period C.

During Period C of the trial, 42% (n=14) of patients using RELiZORB stopped taking PERT capsules1

  • Despite protocol instructions to maintain their usual treatment practice

Long-term Study Results (90 day)2

A prospective, single-arm, multicenter, open-label study of RELiZORB cartridge use with EN tube feedings in patients with CF over a 90-day study period. A total of 36 subjects completed the study with a mean age of 13.8 years, body mass index of 17.7 and 6.2 years mean use of overnight enteral nutrition.2

Endpoints

  • Change over time in red blood cell uptake of DHA and EPA
  • GI symptoms

Visit Assessments:

Height; weight; BMI, vital signs; blood lipids; serum proteins; fatty acid levels, vitamins A, D, and E; AE and UADE assessments

Over 90 days: Changes in Erythorocyte Membrane DHA and EPA Composition (%) also known as Omega-3 Index2

Improvement in Weight Percentiles With Long-term Use of RELiZORB

Overall, weight and BMI z-scores and percentiles were not significantly different from baseline to 90 days. However, 20/33 (61%) of patients had improvement in weight z-scores and percentiles in the intention to treat (ITT) population.2

Long-term usage of RELiZORB showed2

  • No reported incidents 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

All exploratory efficacy outcomes, including serum levels of fat-soluble vitamins A, D, and E in plasma as well as serum protein (total protein, prealbumin, albumin, and transferrin) levels, were within normal ranges at study entry and remained so throughout the 90-day study treatment period.2

DHA=docosahexaenoic acid. EPA=eicosapentaenoic acid
Period A=baseline run-in period. Period C=open-label safety period. UADE=unanticipated adverse device effect. PERT=pancreatic enzyme replacement therapy.
Gastrointestinal events are expressed as: number of events (number of patients reporting events).
GSD=Gastrointestinal Symptom Diary.
    REFERENCES
  1. 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.
  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;67(4):527-532.
  3. Harris WS, Sands SA, Windsor SL, et al. Omega-3 fatty acids in cardiac biopsies from heart transplantation patients: correlation with erythrocytes and response to supplementation. Circulation. 2004;110(12):1645-1649.
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