Relizorb Use Supports Weight, Height Gains in Tube-fed Patients, Study Finds

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by Forest Ray PhD |

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Relizorb, Alcresta Therapeutics‘ pancreatic enzyme treatment, led to significant weight and height improvements among cystic fibrosis (CF) patients with pancreatic insufficiency who require tube feeding, according to the results of a 12-month observational study.

The analysis of that study, “Evaluation of the Effectiveness of In-line Immobilized Lipase Cartridge in Enterally Fed Patients with Cystic Fibrosis,” was published in the Journal of Pediatric Gastroenterology and Nutrition.

In CF patients, a thick mucus develops in organs that can include the pancreas, blocking the release of enzymes like pancreatic lipase, needed to digest food. This condition, known as pancreatic insufficiency, affects patients’ height, weight, and body mass index (BMI, a measure of body fat based on height and weight ).

Relizorb consists of a cartridge that mimics the function of pancreatic lipase — an enzyme specifically needed to absorb fats — immobilized on beads (iLipase) fixed to the end of a feeding tube. As feeding formula passes the cartridge, the iLipase breaks fat in the formula down into more absorbable molecules.

To study Relizorb’s effectiveness in a real-world setting, investigators from Alcresta and two academic institutions collected   height, weight, and BMI data on 100 CF patients, from infants through adults up to age 45, over one year. These data, collected at six and at 12 months, were compared with measures taken at the study’s start (baseline).

At six months, patients older than age 2 (93 of these 100 people) saw significant weight and height improvements that were sustained over the course of the study, meaning they continued to be evident.

At 12 months, the proportion of patients in the 50th percentile or greater for BMI — a goal set by the Cystic Fibrosis Foundation — had steadily increased from 37.1% at baseline to 50%.

The proportion also increased of patients achieving at least the 50th percentile for weight over the study period, although not for height.

“We are excited by the implications of these real-world data in enterally fed patients with cystic fibrosis who are vulnerable to fat malabsorption,” Dan Orlando, CEO of Alcresta, said in a press release. “The one-year Relizorb results are even more impressive when you consider that caloric intake through enteral feeding represents on average just 20% of the overall caloric intake in patients with cystic fibrosis”

Relizorb can break down more than 90% of fats in most enteral feeding tube formulas tested, the company reports, including those most difficult but critical for growth and development: long-chain polyunsaturated fatty acids, such as the omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid (both found in foods like salmon and tuna), and the omega-6 fatty acid arachidonic acid (foods like poultry).

Alcresta provided Relizorb to study participants through a structured program, as reimbursement efforts were ongoing at the time. Insurers have argued that Relizorb remains too experimental to cover.

In an opinion piece published in 2019, CF experts (largely gastroenterologists, physicians, and dietitians) also strongly supported this pancreatic enzyme treatment for those on tube feeding, citing  its benefits reported in clinical studies and reviews, and their own experiences working with patients.

“Our hope is that payers will consider this data, along with previous publications, when establishing medical policy and follow Aetna’s and CIGNA’s lead as they both recently determined Relizorb to be medically necessary for persons with cystic fibrosis on enteral feedings,” said Eric R. First, MD, chief scientific officer at Alcresta.