Business
Achieve Reports Financial Results for Second Quarter 2021 and Provides Corporate Update
SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 12, 2021 / Achieve Life Sciences, Inc. (Nasdaq:ACHV), a clinical-stage pharmaceutical company committed to
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 12, 2021 / 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 second quarter 2021 financial results and provided an update on the cytisinicline clinical development program.Recent Events & HighlightsAnnounced completion of enrollment in the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily (TID) compared to placebo in adult smokersAwarded grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) for the evaluation of cytisinicline in cessation of nicotine e-cigarette useIssued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimenClosed financing with gross proceeds of $23 million, prior to deducting underwriting discounts and offering expenses\"In the second quarter, we continued to demonstrate our commitment to stakeholders by delivering on key milestones that advance our clinical program, and ultimately, cytisinicline's potential ability to help millions of people who struggle with nicotine addiction to live healthier lives,\" commented John Bencich, Chief Executive Officer of Achieve. \"We will remain committed to the execution of the combustible cigarette cessation program, while in parallel preparing for our anticipated expansion into the e-cigarette cessation indication in partnership with the NIH.\"Phase 3 ORCA-2 Trial Fully EnrolledThe Phase 3 ORCA-2 trial completed enrollment of 810 adult smokers at 17 clinical sites in the United States. The participants have been randomized to one of three study arms to determine the efficacy and safety of cytisinicline administered for either six or twelve weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the six and twelve-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-2 d...