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BRIEF-Aradigm announces top-line results from two phase 3 studies evaluating Pulmaquin
December 1, 2016 / 12:35 PM / a year ago

BRIEF-Aradigm announces top-line results from two phase 3 studies evaluating Pulmaquin

Dec 1 (Reuters) - Aradigm Corp -

* Aradigm announces top-line results from two phase 3 studies evaluating pulmaquin for the chronic treatment of non-cystic fibrosis bronchiectasis patients with lung infections with pseudomonas aeruginosa

* Orbit-3 and orbit-4 pivotal trials were identical in design except for a pharmacokinetics sub-study that was conducted in one of trials

* Both studies demonstrated a statistically significant reduction in P. Aeruginosa density at day 28, end of first on-treatment period

* In orbit-4 median time to first mild, moderate or severe pe was 230 days in pulmaquin treatment group as compared to 163 days in placebo group

* Received final statistical analysis report from two year inhalation carcinogenicity study in rats with pulmaquin

* Increase in median time to first pe was statistically significant (P=0.0462) using non-stratified log-rank analysis in orbit-4

* In orbit-3, increase in median time to first pe was similar to orbit-4 but was not statistically significant using non-stratified log-rank analysis

* Pulmaquin was safe and well tolerated in both studies

* Received final statistical analysis report from two year inhalation carcinogenicity study in rats with pulmaquin

* Report from 2 year inhalation carcinogenicity study in rats showed there were no differences in rate of observed tumors between pulmaquin, control groups

* There were 8 deaths in orbit-3, 6 deaths in orbit-4; none of deaths was related to pulmaquin or placebo Source text for Eikon: Further company coverage:

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