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Data from the ASSURE Study of Long-Term Use of RELiZORB® Published in Journal of Pediatric Gastroenterology and Nutrition

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Largest Prospective Trial of Enteral Feeding in Cystic Fibrosis Shows
Sustained Use of RELiZORB Can Help Hydrolyze Fatty Acids and Normalize
Absorption

Alcresta Therapeutics, Inc., a company dedicated to developing and
commercializing novel, enzyme-based products designed to address
challenges faced by patients living with gastrointestinal disorders and
rare diseases, today announced new data published in the Journal
of Pediatric Gastroenterology and Nutrition
regarding RELiZORB
(iMMOBILIZED LIPASE) CARTRIDGE, an in-line digestive enzyme cartridge
indicated for use in pediatric patients (ages 5 years and above) and
adult patients to hydrolyze fats in enteral formula. Data from the
ASSURE study evaluating the long-term safety, tolerability, and
improvement of fatty acid status with RELiZORB in patients with cystic
fibrosis (CF) show that, in a population known to have deficiencies in
critical fatty acids, use of RELiZORB resulted in significant increases
of the fatty acids DHA and EPA over 90 days.

"The improvements in these critical long chain polyunsaturated fatty
acid levels seen in this longer term trial have major implications not
only in growth and weight parameters, but also in potentially
attenuating the excessive inflammation that underlies cystic fibrosis,"
said Steven Freedman, M.D., Ph.D., Chief, Division of Translational
Research at Beth Israel Deaconess Medical Center.

Despite having used oral pancreatic enzyme replacement therapy (PERT)
capsules with overnight enteral feedings for an average of 6 years,
patients entering the study had low levels of DHA and EPA reflecting a
poor nutritional status. During the study, participant DHA and EPA
levels normalized, indicating improvement in absorption of fats with the
use of RELiZORB.

Key Findings:

  • A 2.1-fold increase in red blood cells of DHA and EPA and a 2.3-fold
    increase in plasma levels
  • A 2.2-fold decrease of omega 6:3 ratio, a key marker of inflammation
  • Improvements were found across all age groups and were independent of
    the severity of disease or duration of enteral nutrition
  • 61% of participants had improvement in weight percentiles, with
    similar increases observed in the 5 to 12 year and 13 to 18 year age
    groups
  • All exploratory efficacy outcomes, including serum levels of
    fat-soluble vitamins A, D, and E in plasma as well as serum protein
    (total protein, pre-albumin, albumin, and transferrin) levels, were
    within normal ranges at study entry and remained so throughout the
    90-day study treatment period
  • Decreased frequency of GI symptoms was observed with sustained
    RELiZORB use
  • Long-term use of RELiZORB was found to be safe and well tolerated, and
    RELiZORB use was not associated with any unanticipated adverse events

The omega-3 index used in ASSURE provides a measure of DHA and EPA
levels in red blood cells and is a reliable estimation of long-chain
polyunsaturated fatty acid (LCPUFA) absorption and tissue accretion in
patients with cystic fibrosis. This index was first used as a predictor
of cardiovascular outcomes and is being applied to studies of patients
with cystic fibrosis.

"We're excited by the findings from ASSURE, which represents the largest
prospective study to date in patients with cystic fibrosis receiving
enteral formula. These findings, when added to our previously published
randomized study evaluating the short-term use of RELiZORB in patients
with cystic fibrosis on enteral tube feeding, supplement the growing
body of evidence to validate the benefits of RELiZORB," said Daniel
Tassé, Chief Executive Officer, Alcresta Therapeutics, Inc. "We are
continuing to invest in the RELiZORB development program in order to
generate data as part of our commitment to providing options for
patients who require enteral nutrition."

This is the second study published in the Journal of Pediatric
Gastroenterology and Nutrition
evaluating RELiZORB in the cystic
fibrosis patient population, and the results expand on what was found in
the first published study.

About the ASSURE Study

The Absorption and Safety with Sustained Use of RELiZORB Evaluation
(ASSURE) study is the largest prospective study to date in patients with
cystic fibrosis on enteral formula. The open label study looked at 39
patients, representing approximately 1% of the cystic fibrosis enteral
feeding population, who ranged in age from 5 to 33 (mean age, 13.8
years) at 10 US cystic fibrosis treatment centers. The study period was
90 days, following a 7 day run-in period. RELiZORB was administered with
overnight enteral formula. PERT was used with oral food intake but not
with overnight feeding.

About Alcresta® Therapeutics, Inc.

Alcresta Therapeutics, Inc. is dedicated to developing and
commercializing novel, enzyme-based products designed to address
challenges faced by patients living with gastrointestinal disorders and
rare diseases. The company uses its proprietary technology platform to
support a broad pipeline of products, with an initial focus on
pancreatic insufficiency, which results in malabsorption common in
cystic fibrosis, digestive cancers, premature birth and other serious
diseases.

The Alcresta Therapeutics, Inc. management team has extensive experience
in pharmaceutical, medical devices, and nutritional product development.
The corporate office is based in Warren, New Jersey with additional R&D
sites in the Boston, MA area and is backed by top-tier investors:
Athyrium Capital Management, Bessemer Venture Partners, HealthQuest
Capital, Frazier Healthcare Partners, and Third Rock Ventures. More
information can be found at www.alcresta.com.

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