Achieve Life Sciences Initiates Pivotal Trial Of Cytisinicline For Smoking Cessation

Achieve Life Sciences Inc 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.