Achieve Life Sciences, Inc. announced positive topline results from a second Phase 3 ORCA-3 trial, which confirmed the safety and efficacy of 3mg cytisinicline dosed three times daily versus placebo in 792 adult U.S. smokers. Consistent with the previously reported Phase 3 ORCA-2 study, ORCA-3 demonstrated a statistically significant benefit in helping smokers quit compared to placebo, with low rates of adverse events. Both the 6-week and 12-week treatment durations showed statistically significant smoking cessation rates during the last 4 weeks of treatment and continued smoking abstinence through the follow up period of 24 weeks.

Subjects had an average age of 53 years, smoked a median of 20 cigarettes per day at baseline, and had a median smoking history of 36 years with four prior quit attempts. Cytisinicline was well-tolerated, and no treatment-related serious adverse events were reported. The findings highlighted cytisinicline's potential as an effective and well-tolerated treatment option for those who suffer from nicotine dependence.

ORCA-V1 Positive Phase 2 Trial Results for Vaping Cessation: Statistically significant results from the Phase 2 ORCA-V1 trial were also reported in the second quarter of 2023. Participants who underwent 12 weeks of cytisinicline treatment showed a 2.6 times higher likelihood of quitting vaping during the last 4 weeks of treatment compared to the placebo group (p=0.035). The vaping cessation rate from weeks 9 to 12 was 31.8% for cytisinicline compared to 15.1% for placebo.

Favorable results for cytisinicline were consistently observed in secondary endpoints, across various clinical trial sites, and among different demographics, including age, gender, race, and prior smoking history. Cytisinicline was well-tolerated, with no reports of serious adverse events.