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Restore CFTR Protein Completed with Results

SNO6: Phase 2 study of N91115 in adults with CF who are currently taking lumacaftor/ivacaftor (Nivalis N91115-2CF1-05)

This study evaluated the safety and effectiveness of the CFTR modulator drug N91115 (cavosonstat). This study was for adults with cystic fibrosis who have two copies of the F508del CFTR mutation and were also taking lumacaftor/ivacaftor (Orkambi®).

 Participants in the study were randomly assigned to receive either cavosonstat twice daily (200mg or 400mg) or placebo for 12 weeks. After the 12 week treatment period, participants entered a 4-week withdrawal period where they stopped taking cavosonstat and continued taking their usual lumacaftor/ivacaftor.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40 to 85%

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

Other Primary Eligibility Criteria

Only patients homozygous for the F508del CFTR mutation will be included. Subjects must have been treated with lumacftor/ivacaftor for at least 8 weeks prior to dosing, and there must be evidence of their pre-treatment FEV1 with that combination.

Study Results

  • What We Learned:

    This study found that cavosonstat, a CFTR modulator, did not have a significant impact on improving lung function or reducing sweat chloride. Cavosonstat was well-tolerated.  No further clinical development in CF is planned at this time.

  • Primary Findings:

    Effectiveness:

     

    This study was conducted between October 2015 and October 2016. The study enrolled 138 participants (n=44 cavosonstat 200mg; n=48 cavosonstat 400mg; n=46 placebo).

     

    The primary endpoint of this study was change in lung function from before the study to after 12 weeks of cavosonstat treatment. This was measured by the absolute change in ppFEV1. This study did not meet the primary endpoint as cavosonstat did not have a significant impact on change in lung function.

     

    Additionally, cavosonstat did not have a significant impact on sweat chloride reduction.

    Safety:

    Cavosonstat was well-tolerated.

     

    These results have been provided from a Nivalis Press Release and have not been peer reviewed.

  • 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

    Yes

  • Length of Participation:

    16 weeks

  • Number of Study Visits:

    10

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40 to 85%

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

Other Primary Eligibility Criteria

Only patients homozygous for the F508del CFTR mutation will be included. Subjects must have been treated with lumacftor/ivacaftor for at least 8 weeks prior to dosing, and there must be evidence of their pre-treatment FEV1 with that combination.

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