Research Corner: Alcresta’s RELiZORB is the only FDA approved enteral feeding EnZyme
By Ella Balasa
As people with CF, many of us have struggled with being underweight throughout our lives. We don’t absorb fats well due to exocrine pancreatic insufficiency (EPI) despite taking daily doses of pancreatic enzymes (PERT). For those that supplement high calorie diets with enteral (tube) feeding, Alcresta Therapeutics has developed a new enzyme product innovation called RELiZORB that is designed specifically to optimally break down the fats in the tube feed before it is absorbed in the gut. It uses a cartridge design to mimic the function of pancreatic lipase.
How does RELiZORB work?
Inside the cartridge is a digestive enzyme called lipase, which is attached to the small white beads that you can see through the clear cartridge. As the enteral tube feeding formula passes through RELiZORB, it makes contact with the lipase-enzyme bead combination (called iLipase™), and the fat in the formula is broken down to its absorbable form called fatty acids and monoglycerides. The fats that are now broken down to their absorbable form leave the cartridge and enter your body, while the iLipase remains in the cartridge.
RELiZORB is best used in continuous feeding, like overnight tube feeds. If someone were to take a regular digestive enzyme like Creon or Zenpep by mouth instead of using RELiZORB, these enzymes would break down quickly in the first hour or two of tube feeding and the remaining formula would not be properly digested as there would be no enzymes present to break down the fats.
How does this enzyme differ from other PERT therapy options?
RELiZORB has been shown to break down more than 90 percent of fats in most enteral feeding tube formulas tested, including the most difficult to break down long-chain polyunsaturated fatty acids (LCPUFAs), such as the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and the omega-6 fatty acid arachidonic acid, all of which are critical for growth and development.
The goal of enteral feeding is to increase caloric intake to support optimal weight gain in those at nutritional risk and RELiZORB breaks down critical fats immediately prior to ingestion, mimicking the function of the digestive enzyme lipase that is normally secreted by the pancreas.
What did RELiZORB’s clinical trial results yield?
Two published pivotal clinical trials on RELiZORB in pediatric and adult patients met their primary endpoints demonstrating an almost 3-fold increase in the absorption of key Omega-3 fatty acids after a single RELiZORB use and normalized fat absorption over 90 days with daily RELiZORB use. Of participants, 61% demonstrated improvement in weight percentiles. The safety and efficacy of RELiZORB has further been validated by real world reported experience from a number of academic institutions.
A most recent 12-month observational study examined the effectiveness of RELiZORB in real-world patients use by a cohort of enterally fed patients with CF.
At just six months of use, patients in their active growth years demonstrated significant improvements in both weight and height from baseline. The proportion of patients achieving the Cystic Fibrosis Foundation BMI goal of ≥ 50th percentile increased steadily from 37.1% at baseline to 50.0% at 12 months.
Are you interested in trying RELiZORB?
RELiZORB Is eligible for reimbursement as medically necessary. It is covered and reimbursed under the permanent Centers for Medicare & Medicaid Services’ HCPCS code B4105. There is also an out of pocket assistance program and a patient assistance program (PAP).
You can speak with a local Case Manager regarding access by calling the RELiZORB Support Services Team at 1-844-632-9271, or visit www.RELiZORB.com for more information.
You can also find more tips and resources by joining the RELiZORB Facebook community.
About the Author: Ella is a director for USACFA. She was diagnosed with CF at 18 months old. She has a B.S. in biology and serves on various research committees, authors journal submissions, and shares her health journey to provide a scientific voice and encourage empowerment to the CF community. She also writes about the hardship yet triumph of chronic disease. When she is not taking care of her health, she enjoys cooking, drawing, and spending time with friends. View more of her work and experiences on her website, www.ellabalasa.com.