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Nutritional-GI Completed with Results

OPTION 2: Study of AzurRX MS1819 in enteric capsules in adults with cystic fibrosis and exocrine pancreatic insufficiency (AzurRX AZ-CF2002)

This study evaluated the safety and effectiveness of the drug MS1819 as a pancreatic enzyme replacement therapy (PERT). MS1819 is a non-porcine (not pig-derived) lipase-only enzyme for people with CF who have exocrine pancreatic insufficiency (EPI).

 This study was a crossover trial. Arm 1 participants were randomly assigned to either receive porcine PERT for three weeks followed by MS1819 (2240 mg/day) for three weeks, or to receive the study drug followed by PERT in opposite sequence. Arm 2 participants were randomly assigned to either receive porcine PERT for three weeks followed by MS1819 (4480 mg/day) for three weeks, or the opposite sequence. To assess MS1819 effectiveness, the coefficient for fat absorption (CFA) was measured at the end of each 3-week treatment period. 

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    30% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Results

  • What We Learned:

    This study confirmed earlier results (NCT03746483) that MS1819, a lipase-only non-porcine PERT, was overall well-tolerated, although symptoms of EPI were more prominent when taking MS1819 compared with porcine PERT. The mean CFA for porcine PERT was 83% in Arm 1 and 89% in Arm 2. In comparison, the mean CFA for MS1819 was significantly lower: 66% for the 2240 mg dose and 53% for the 4480 mg dose. The effectiveness of MS1819 does not increase above 2240 mg dosage.

  • Primary Findings:

    Effectiveness:

    The mean CFA for porcine PERT was 83% in Arm 1 and 89% in Arm 2. In comparison, the mean CFA for MS1819 was significantly lower: 66% for the 2240 mg dose and 53% for the 4480 mg dose. 

     

    The study also evaluated the coefficient of nitrogen absorption (CNA). The mean CNA for porcine PERT was 97% in Arm 1 and 98% in Arm 2. In comparison, the mean CNA for MS1819 was significantly lower: 94% for the 2240 mg dose and 91% for the 4480mg dose. 

    Safety:

    This study was conducted between July 2020 and April 2021. This study enrolled 27 participants of whom 24 completed the treatment period. 

    Symptoms of EPI were more prominent in the MS1819 group. Overall, MS1819 was well-tolerated. There were no serious adverse events (SAE) during the treatment period.

     

    Results have not been peer-reviewed and come from https://clinicaltrials.gov/study/NCT04375878 

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    8 weeks

  • Number of Study Visits:

    10

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Entero Therapeutics (Formerly AzurRx BioPharma, Inc and First Wave)

  • Study Drugs:

    Adrulipase (formerly MS1819-SD)

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    30% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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