Achieve Life Sciences Aces Pivotal Cytisinicline Study In Smoking Cessation

Achieve Life Sciences Inc ACHV has announced positive topline results from the Phase 3 ORCA-2 trial of 3mg cytisinicline for 6-weeks or 12-weeks compared to a placebo in 810 adult smokers.
The 6- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo, with odds ratios of 8.0 and 6.3, respectively.
Subjects who received 12 weeks of cytisinicline treatment had a 6.3 times higher likelihood of quitting smoking during the last 4 weeks of treatment than subjects who received placebo.
The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.
Subjects who received 6 weeks of cytisinicline treatment had an 8 times higher likelihood of quitting smoking, with an abstinence rate of 25.3% compared to 4.4% for placebo.
The continuous abstinence rate from week 9 to 24 was 21.1% for the 12-week cytisinicline arm compared to 4.8% for placebo, with an odds ratio of 5.3.
The continuous abstinence rate from week 3 to 24 was 8.9% for the 6-week cytisinicline arm compared to 2.6% for placebo, with an odds ratio of 3.7.
Cytisinicline was well tolerated, with no treatment-related serious adverse events reported.
After the data, Achieve Life Sciences can withdraw the remaining $10 million under the $25 million debt facility from Silicon Valley Bank.
Price Action: ACHV shares are down 6.52% at $6.45 during the market session on the last check Wednesday.