Achieve Life Sciences Inc. ACHV said Tuesday a second confirmatory late-stage trial of its cytisinicline for quitting smoking and nicotine dependence achieved positive results, showing a statistically significant benefit compared to placebo. The Phase 3 trial involved 792 adult smokers at 20 trial sites in the U.S. who were dosed 3 times daily with 3mg of cytisinicline for a period of six weeks or 12 weeks. The primary endpoint was biochemically verified smoking cessation for 24 weeks post randomization. “Both the 6- and 12-week cytisinicline treatment durations demonstrated statistically significant smoking cessation on both the primary and secondary efficacy analyses compared to placebo,” the company said in a statement. There are an estimated 28.3 million adults in the U.S. who smoke and more than 1 billion people globally. Some 8 million people die of smoking-related illnesses every year, according to Achieve Life Sciences. The company is now working with regulators to bring cytisinicline to market. The stock was up 1.6% premarket and has gained 233% in the year to date, while the S&P 500 SPX has gained 9%.
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