Major Data Announcement from Achieve Life Sciences’ Phase-3 ORCA-2 Study

Today Achieve Life Sciences reached a major milestone, reporting positive results from our Phase 3 clinical study, ORCA-2. Results for the primary endpoint of the study show 6-8 times higher odds, or increased likelihood, of smoking abstinence with cytisinicline compared to placebo. Cytisinicline was well tolerated with single-digit rates of adverse events observed.

These positive results are especially impressive as we’ve seen a major decline in smoking cessation over the past two years. COVID-19 increased many people’s stress levels, leading people to turn to substance use, and the lack of day-to-day structure and social outings left many people unmotivated to live a healthier lifestyle. Unfortunately, for the first time in 20 years the Federal Trade Commission report showed an increase in cigarette purchases in 2020.

This increase, compounded with the fact that it has been more than 15 years since the U.S. Food and Drug Administration approved a new smoking cessation option makes the timing of these ORCA-2 results of the utmost importance.

We are hopeful for what these ORCA-2 outcomes mean for the development of cytisinicline and the health of over 34 million U.S. smokers. Smoking is still currently the leading cause of preventable death in the United States and is a significant risk factor for cancer, heart disease, stroke, lung diseases, diabetes, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, and reduced male and female fertility. These results reiterate our confidence that cytisinicline can help treat nicotine addiction effectively, even during a pandemic when stress levels were — and for many people continue to be — at an all-time high.

To learn more about the ORCA-2 topline results and cytisinicline, click here: https://achievelifesciences.com/#1