SEATTLE and VANCOUVER, British Columbia, Jan. 25, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced it has initiated screening of ORCA-3, the confirmatory Phase 3 trial required for registrational approval of cytisinicline in the United States. ORCA-3 will evaluate the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites.
Similar to the first registrational Phase 3 ORCA-2 trial, 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. All subjects will receive standard behavioral support and will be assigned to one of the following groups:
- Arm A: 12 weeks of placebo
- Arm B: 6 weeks of cytisinicline, followed by 6 weeks of placebo
- Arm C: 12 weeks of cytisinicline
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, and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Secondary outcome measures will be conducted to assess continued abstinence rates through 6 months from the start of study treatment.
“With the kickoff of the ORCA-3 trial, upcoming topline data results from ORCA-2, and the anticipated initiation of the ORCA-V1 e-cigarette cessation trial, we believe 2022 will be a pivotal year for Achieve,” stated John Bencich, Chief Executive Officer of Achieve. “We are grateful for the ORCA-3 investigators and the trial’s future participants who are committed to quitting smoking in the New Year.”
Achieve recently announced completion of the last subject visit in the ongoing Phase 3 ORCA-2 trial, with topline data results expected in the second quarter of 2022. Additionally, the grant-funded 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 the second quarter of 2022, subject to grant funding timelines.
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