Business
Achieve Reports Financial Results for Third Quarter 2022 and Provides Corporate Update
Company to host conference call at 4:30 PM EST today, November 14, 2022 SEATTLE and VANCOUVER, British Columbia, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Achieve
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Company to host conference call at 4:30 PM EST today, November 14, 2022\nSEATTLE and VANCOUVER, British Columbia, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced third quarter 2022 financial results and provided an update on the cytisinicline development program. Highlights Completion of targeted enrollment in Phase 3 ORCA-3 clinical trial of cytisinicline in 750 adult smokers was announced in SeptemberEarly completion of targeted enrollment in the Phase 2 ORCA-V1 clinical trial of cytisinicline in 150 adult nicotine e-cigarette users was announced in NovemberNew active pharmaceutical ingredient (API) suite construction completed by Sopharma, expanding the global commercial manufacturing capacity for cytisinicline “Completing enrollment in the ORCA-3 trial this quarter and more recently, the ORCA-V1 trial, has moved us closer to potentially bringing a critical treatment option to people who wish to end their nicotine dependence,” stated John Bencich, CEO of Achieve Life Sciences. “We are excited to build upon the previously reported cessation benefit, safety, and tolerability of cytisinicline and look forward to releasing top-line data for both trials in the second quarter of next year.” Completed Enrollment in Confirmatory Phase 3 ORCA-3 TrialIn September, Achieve announced the completion of targeted enrollment of 750 adult smokers in its confirmatory Phase 3 ORCA-3 clinical trial of cytisinicline being conducted across 20 clinical trial locations in the United States. The participants in ORCA-3 were randomized to one-of-three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. Similar to the previously reported ORCA-2 trial, the primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to 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. Topline ORCA-3 data are curr...