Business
Achieve Reports Financial Results for Third Quarter 2021 and Provides Update on Cytisinicline Development
SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 09, 2021 (GLOBE NEWSWIRE) -- -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"SEATTLE, Wash and VANCOUVER, British Columbia, Nov. 09, 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 third quarter 2021 financial results and provided an update on the cytisinicline clinical development program. Recent Highlights Provided an update on the ORCA-2 Phase 3 clinical trial, including announcing that all subjects have completed the treatment portion of the study and are in follow-up, and that topline data is expected in the first half of 2022 Discussed ongoing planning activities for ORCA-3, the second Phase 3 clinical trial supporting cytisinicline regulatory submission in the United States, which Achieve anticipates could launch by early 2022Announced FDA acceptance of IND application for the evaluation of cytisinicline in nicotine e-cigarette cessationIssued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimenPresented cytisinicline data at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) annual meetingAnnounced expansion of cytisinicline clinical operations team “It has been another successful quarter as we continue to focus on meeting our key development milestones, specifically, completing the Phase 3 ORCA-2 trial, and preparing for the initiation of two new cytisinicline trials,” commented John Bencich, Chief Executive Office of Achieve. “We are looking forward to an exciting year ahead with the expected ORCA-2 Phase 3 data results, the start of our second Phase 3 study in cigarette smoking cessation and launch of the grant-funded ORCA-V1 trial in e-cigarette cessation.” Ongoing ORCA-2 Phase 3 Clinical Trial Achieve provided an update on the cytisinicline development program in adult cigarette smokers in the United States. The ORCA-2 Phase 3 trial completed enrollment of 810 subjects. To date, all subjects have completed study treatment and are currently in follow-up. The last subject is expected to complete their final visit by the end of 2021, with topline data expected to be announced in the first half of 2022. Planned ORCA-3 Phase 3 Clinical Trial Achieve reviewed ORCA-3 planning activities and announced that it has compl...