Study Results

• What We Learned:

  This study found that the drug, N91115, was safe and well tolerated, Overall, treatment with N91115 did not have any significant impact on lung function or sweat chloride value when compared with placebo. However, participants taking the highest dose tested (200 mg) had a small reduction from baseline in sweat chloride value (-4.1 mmol/L), which led researchers to conduct further studies on N91115.

• Primary Findings:

  Effectiveness:

  Safety:

  This manuscript combined data from three clinical trials evaluating N91115: SN02, SN04, and SN05. Both SNO2 and SNO5 were studies of healthy volunteers; SNO4 enrolled people with cystic fibrosis. These results focus on the outcomes of the SNO4 trial. This study was conducted between January 2015 and August 2015. A total of 51 participants were randomized to receive N91115 at three different doses (50mg: n=12, 100mg: n=13, and 200mg: n=14) or placebo (n=12). The primary endpoint of this study was safety and tolerability. N91115 was well tolerated with the adverse event profile being similar between the N91115 groups and placebo. Researchers in this relatively small study also looked at lung function (measured by FEV1) and change in sweat chloride after 28 days of dosing. There was no significant difference in any of the three N91115 dose groups in change from baseline in lung function or sweat chloride value when compared with placebo. Participants taking the highest dose tested (200 mg) had a small reduction from baseline in sweat chloride value (-4.1 mmol/L).

• Citation:

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