Achieve Life Sciences Inc ACHV announced topline results from the second Phase 3 ORCA-3 trial of cytisinicline.
Consistent with the previously reported Phase 3 ORCA-2 study, ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events.
The 6- and 12-week cytisinicline treatment durations demonstrated statistically significant smoking cessation on the primary and secondary efficacy analyses compared to placebo.
Primary Endpoint: Subjects who received 12 weeks of cytisinicline treatment had 4.4 times higher odds, or likelihood, to quit smoking during the last four weeks than subjects who received a placebo.
The smoking cessation rate during weeks 9 through 12 was 30.3% for cytisinicline compared to 9.4% for placebo.
Secondary Endpoint: The continuous smoking cessation rate from week 9 to week 24 was 20.5% for the 12-week cytisinicline arm compared to 4.2% for the placebo, with an odds ratio of 5.79.
Subjects who received six weeks of cytisinicline treatment had 2.85 times higher odds, or likelihood, to quit smoking during the last four weeks than subjects who received a placebo.
The smoking cessation rate during weeks 3 through 6 was 14.8% for cytisinicline compared to 6% for placebo.
The continuous smoking cessation rate from week 3 to week 24 was 6.8% for the 6-week cytisinicline arm compared to 1.1% for the placebo, with an odds ratio of 6.25.
Price Action: ACHV shares are down 20.50% at $6.48 on the last check Tuesday.
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