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Nutritional-GI Completed with Results

OPTION: Study of AzurRx MS1819 in people with cystic fibrosis (CF) and exocrine pancreatic insufficiency who are 18 years and older (AzurRX AZ-CF2001)

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 two-part crossover trial where participants received both MS1819 and porcine PERT. In Part 1, participants were randomly assigned to receive porcine PERT or MS1819 (2240 mg/day) for three weeks. After Part 1, coefficient for fat absorption (CFA) was obtained. In Part 2, participants received the opposite treatment than what they received in Part 1 for three more weeks. At the end of Part 2 another CFA measurement was obtained.

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 found that MS1819, a lipase-only non-porcine PERT, was overall well-tolerated, though symptoms of EPI were more prominent when taking MS1819 when compared with porcine PERT. The mean CFA for the MS1819 overall was 56% (range 7% to 92%) and the mean CFA for the porcine PERT overall was 86% (range 57% to 97%). The mean CFA of 56% on MS1819 was substantially lower than the mean CFA obtained with porcine PERT. Further development of MS1819 is ongoing in the OPTION 2 trial (NCT04375878).

  • Primary Findings:

    Effectiveness:

    Safety:

    This study was conducted between February 2019 and May 2019. This study enrolled 41 participants and 33 completed both Part 1 and 2.

     

    Symptoms of EPI were more prominent in the MS1819 group. Overall, MS1819 was well-tolerated. Three serious adverse events (SAE) occurred during the screening period, but none during the trial. Each of these SAEs was due to pulmonary exacerbations of CF.

     

    The mean CFA for the MS1819 overall was 56% (range 7% to 92%) and the mean CFA for the porcine PERT overall was 86% (range 57% to 97%). The mean CFA of 56% on MS1819 was substantially lower than the mean CFA obtained with porcine PERT. The study also looked at coefficient of nitrogen absorption (CNA). The mean CNA for the MS1819 group was 93% (range 87%-98%) and the mean CNA for the PERT group was 97% (range 93%-99%).

     

    CFA efficacy of MS1819 may be enhanced with a higher dose and/or a capsule that protects MS1819 from the acidic gastrointestinal system. Further development of MS1819 is ongoing in the OPTION 2 trial (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:

    11 weeks

  • Number of Study Visits:

    10

Additional Information

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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