Investigational treatment Encala (Lym-X-Sorb) is safe, well tolerated, and increased dietary fat absorption in patients with cystic fibrosis (CF) and pancreatic insufficiency, according to an analysis from a Phase 2 clinical trial.
Findings from the analysis were reported in the study, “Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial,” published in the journal PLOS One.
While CF is most commonly associated with the lungs, it can also affect digestion, impairing nutrient absorption, including fats, and leading to poor nutrition, which, in turn, has an impact on the height and weight in children.
“Malnutrition due to chronic malabsorption is an important intervention target in CF care as it affects growth, development, pulmonary function, immune system function, and survival,” the study’s researchers wrote.
To address this, Envara Health developed Encala, an oral treatment specifically designed to increase fat absorption in CF patients.
The Phase 2 trial (NCT00406536), which ran between 2007 and 2012, investigated Encala as a nutritional supplement in patients with CF and pancreatic insufficiency.
Researchers have now conducted a subgroup analysis of the trial to determine if the “effect of three months of Encala treatment varied by subject degree of dietary fat malabsorption at baseline,” they wrote.
The analysis included a total of 66 children with CF, ages 5 to 17.9 years, recruited at 10 CF centers across the U.S. The participants were randomly assigned to either Encala or a placebo group by an independent team at the Children’s Hospital of Philadelphia, using a method that ensured diversity of age and sex in each group.
Participants who were 5–11.9 years old were given two packets of either Encala or a placebo per day, and those ages 12–17.9 were given three packets.
To evaluate fat intake, the researchers primarily used a measurement called coefficient of fat absorption (CFA), which uses a stool sample to determine how much fat was absorbed in digestion. The CFA value was measured in participants at the start of the trial, as well as after three months of treatment.
Patients were categorized by their initial CFA measure, which was considered high (88% or higher) in half of participants and low (less than 88%) in the other half. The accepted range for healthy absorption is a CFA of 93% or higher.
Results showed that, in the low CFA group, those who received Encala showed a significant increase in CFA after three months — a mean 7.5% increase. The high CFA Encala group, as well as the high and low CFA groups who received the placebo, did not show a significant change in CFA.
The low CFA group also showed significant improvements in fat levels measured from blood samples, as well as height, weight, and body mass index measurements.
Encala treatment was also safe and well tolerated among the participants.
“In summary, subjects with low baseline CFA and more severe fat malabsorption had a dramatic improvement in CFA with Encala treatment, accompanied by improved plasma fatty acid and growth status,” the researchers wrote.
Though further investigation is needed, the researchers were able to demonstrate the effectiveness of Encala for CF patients with pancreatic insufficiency who have difficulty absorbing fat nutrients from their diet.
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