Benzinga | Nov 22, 2021 08:34AM EST

Achieve Life Sciences Reports Phase 3 ORCA-2 Trail Of Cytisinicline In Smoking Cessation Clears Final Review By Data Safety Monitoring Committee

Following the fifth and final DSMC review, committee has concluded no concerns with cytisinicline safety or Phase 3 trial conduct

SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 22, 2021 (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 the completion of the fifth and final Data Safety Monitoring Committee (DSMC) review for its Phase 3 ORCA-2 smoking cessation trial of cytisinicline.

The DSMC concluded that there are no concerns regarding the Phase 3 study conduct and the safety and adverse event profile remains favorable. Additionally, the DSMC members commented that compliance with study medication was excellent and the study has progressed well despite the challenges of the COVID-19 pandemic.

The ORCA-2 trial is designed to evaluate the smoking cessation effectiveness, safety, and tolerability of 3 mg cytisinicline taken three times daily (TID) for either 6 or 12 weeks, compared with placebo. Subjects in the trial have completed study treatment and continue to receive standard behavioral support while completing follow-up assessments through 24 weeks post randomization. Fully enrolled this July, 810 participants were randomized across the 17 clinical sites in the United States. Preliminary data is expected in the first half of 2022.

"We are grateful to the DSMC members for their diligence and guidance during these reviews and are very pleased with the outcome," commented Cindy Jacobs, President and Chief Medical Officer of Achieve. "The successful safety reviews during this ORCA-2 study are important for cytisinicline, as we believe the potential safety and tolerability of cytisinicline will be a key differentiator to existing treatments. We look forward to announcing ORCA-2 topline results in the first half of 2022."