Achieve Life Sciences Inc (NASDAQ:ACHV) has initiated the screening in the ORCA-3 Phase 3 trial of cytisinicline for smoking cessation.
- The trial will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily compared to placebo in 750 adult smokers.
- ORCA-3 participants will be randomized to one of three study arms to evaluate cytisinicline administered for either 6 or 12 weeks, compared to placebo.
- Related: Achieve Life Sciences Secures $25M Loan Facility To Fund Smoking Cessation Program.
- The primary outcome measure of success in the ORCA-3 trial is biochemically verified continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared with placebo.
- Each treatment arm will be compared independently to the placebo arm.
- Secondary outcome measures will be conducted to assess continued abstinence rates through 6 months from the start of study treatment.
- Achieve recently announced completed the last subject visit in the ongoing Phase 3 ORCA-2 trial, with topline data results expected in Q2 of 2022.
- Additionally, the Phase 2 ORCA-V1 study, which is expected to investigate the efficacy of cytisinicline in approximately 150 adult nicotine e-cigarette users, is anticipated to initiate by the end of Q2 of 2022.
- Price Action: ACHV shares are up 0.85% at $7.14 during the market session on the last check Tuesday.
