On May 13, 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, reported first quarter 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAY 13, 2021, View Source [SID1234579924]).

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Recent Events & Highlights

Provided update on the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 17 clinical sites in the United States
Published Phase 2b ORCA-1 safety, efficacy, and compliance results in Nicotine and Tobacco Research
Announced the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to Achieve’s Board of Directors
Published RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix (varenicline) in Addiction
"In the first quarter, we’ve seen great interest and increased momentum in the ORCA-2 trial and look forward to completing enrollment by the middle of the year," commented John Bencich, Chief Executive Officer of Achieve. "We will continue to focus our efforts on execution of the Phase 3, ensuring all required NDA-enabling activities remain on track, and furthering our discussions with potential strategic partners to prepare for cytisinicline commercialization."

Phase 3 ORCA-2 Trial
The Phase 3 ORCA-2 trial continues to enroll at 17 clinical sites in the United States. Approximately 750 adult smokers will be 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. The trial is expected to complete enrollment by the middle of 2021.

ORCA-1 Results Published in Nicotine and Tobacco Research
Results from the Phase 2b ORCA-1 trial were published in the scientific journal Nicotine and Tobacco Research. ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States. The publication reported that subjects treated with cytisinicline, regardless of dose or schedule, had statistically significantly higher (p<0.001) end of treatment abstinence rates compared to those treated with placebo. Participants in the 3.0 mg cytisinicline 3 times daily (TID) arm, were five times more likely to quit smoking than those in the placebo arm (OR of 5.04, 95% CI: 1.42, 22.32, p<0.001). Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported.

Appointment of Drs. Martell and Jacobs to Board of Directors
Achieve announced the appointment of two new members to Achieve’s Board of Directors, Dr. Bridget Martell and Dr. Cindy Jacobs. Dr. Martell is board certified in both Internal and Addiction Medicine and is an experienced executive leader in the pharmaceutical industry. Dr. Jacobs serves as Achieve’s President and Chief Medical Officer, and in addition to her Board of Directors duties, will continue in her current role leading Achieve’s regulatory and clinical development efforts for cytisinicline.

RAUORA Trial Results Published in Addiction
Results from the Phase 3 RAUORA trial were published in the scientific journal Addiction. RAUORA evaluated the effectiveness and safety of cytisinicline compared to Chantix (varenicline) as a smoking cessation aid in 679 indigenous New Zealanders (Māori). The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint, and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), and a 55% improvement in quit rates at six months in favor of cytisinicline when compared to Chantix. A Bayesian analysis of the primary efficacy outcome is ongoing. Additionally, statistically significant fewer overall AEs were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001) including a significantly lower rate of nausea when compared to subjects on Chantix.

Financial Results
As of March 31, 2021, the company’s cash, cash equivalents, and restricted cash was $29.7 million. Total operating expenses for the three months ended March 31, 2021 was $8.0 million. Total net loss for the three months ended March 31, 2021 was $8.0 million.

As of May 13, 2021, Achieve had 6,164,360 shares outstanding.

Conference Call Details
Achieve will host a conference call at 4:30 pm Eastern time today, Thursday, May 13, 2021. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6096445. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.