Achieve Life Sciences Reports Statistically Significant Smoking Cessation Benefit for Cytisinicline in Second, Confirmatory Phase 3 Clinical Trial
ORCA-3 demonstrated statistically significant topline results in primary and secondary smoking cessation endpoints for both 6- and 12-week cytisinicline treatment durations compared to placebo
Cytisinicline demonstrated 6x increase in odds of continuous smoking abstinence at 6 months
Cytisinicline treatment well tolerated with low rates of adverse events reported
Management to host conference call today, May 23 at 8:30AM EDT
SEATTLE and VANCOUVER, British Columbia, May 23, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced positive topline results from the Phase 3 ORCA-3 trial of cytisinicline. Consistent with the previously reported Phase 3 ORCA-2 study, ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events.
ORCA-3 was designed to evaluate the efficacy and safety of 3mg cytisinicline dosed 3 times daily for a period of 6 weeks or 12 weeks compared to placebo. ORCA-3 randomized 792 adult smokers at 20 clinical trial sites in the United States. All participants received standard behavioral support for the duration of the trial. The primary endpoint for ORCA-3 was biochemically verified smoking cessation measured during the last 4 weeks of treatment. Subjects were monitored for smoking cessation for 24 weeks post randomization.
Both the 6- and 12-week cytisinicline treatment durations demonstrated statistically significant smoking cessation on both the primary and secondary efficacy analyses compared to placebo.
12-Week Cytisinicline Efficacy Results
6-Week Cytisinicline Efficacy Results
ORCA-3 subjects had an average age of 53 years, smoked a median of 20 cigarettes per day at baseline, and had a median smoking history of 36 years with 4 prior quit attempts.
Similar to ORCA-2 findings, cytisinicline was well-tolerated with no treatment-related serious adverse events reported. The most commonly reported (>5% overall) adverse events for placebo, 6-week cytisinicline, and 12-week cytisinicline were:
“The ORCA-3 study findings add to a large body of evidence showing that cytisinicline appears to be a very well-tolerated and effective treatment compared to behavioral support alone for people who are dependent on cigarettes and want to quit,” said Dr. Omer Abid, Board Certified Addiction Medicine Physician & Medical Director of Insight Behavioral Health, Principal Investigator at Insight Research Institute, and ORCA-3 Investigator. “Cytisinicline gives hope for future smoking cessation success, given that there are limited available treatments, and many have tolerability limitations that lead to lack of compliance or adoption.”
The health consequences of smoking are widely known, yet the use of combustible nicotine cigarettes continues to be a global health issue. There are an estimated 28.3 mllion adults in the United States, and more than 1 billion people globally that currently smoke. Smoking remains the leading cause of preventable death and disease and claims the lives of an estimated 8 million people worldwide each year. If approved, cytisinicline could be the first new prescription treatment in nearly 20 years to help the millions of people who smoke to overcome nicotine dependence.
“Following the success of our previous clinical trials, and years of research, we are thrilled with the results from this second and confirmatory Phase 3 study of cytisinicline. With more than 2,000 clinical trial participants in our ORCA program to date, we are confident that cytisinicline has the potential to help the millions of people who are battling nicotine dependence,” said John Bencich, Chief Executive Officer of Achieve Life Sciences. “We would like to extend our gratitude to the ORCA-3 trial participants, the healthcare providers, and to everyone who continues to support Achieve’s mission of helping people live better and healthier lives. We are excited about the future and continuing our work with regulators with the aim of bringing cytisinicline to market.”
Conference Call Details
Further information on cytisinicline and Achieve Life Sciences can be found at www.achievelifesciences.com.
About Achieve and Cytisinicline?
In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.3 In 2022, approximately 2.5 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.
Forward Looking Statements
Investor Relations Contact
Continental Breakfast Served - For Diamond, Enterprise, Platinum, Super Pass, Exhibitor/Conference, Speaker, Press Pass Holders
MSP Expo #TECHSUPERSHOW Booth Crawl