SEATTLE, Wash. and VANCOUVER, British Columbia, September 13, 2019 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that two presentations featuring final data from the Phase 2b ORCA-1 trial will be conducted at the SRNT-E Annual Conference on Friday, September 13th in Oslo.
ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported in June of 2019, have led to the selection of 3.0 mg, three times daily (TID) dosing for future Phase 3 development.
The 3.0 mg TID treatment arm demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005). Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval.
Final data included in the oral presentations at SRNT-E indicate statistically significant end-of-treatment abstinence rates of 50-54% for all cytisinicline treatment arms compared to 16% for placebo. Subjects had smoked on average for over 30 years. There were no differences observed in treatment outcomes based on subject demographics, clinical site location, number of prior smoking cessation treatments, or previous quit attempts.
Overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically. Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported. Overall, in subjects treated with cytisinicline, all individual AE’s reported were below a rate of 10%. Minimal rates of abnormal dreams, insomnia, upper respiratory tract infections, and nausea were reported compared with placebo.
Achieve Life Sciences will host an investor day with smoking cessation opinion leaders on Friday, September 20, 2019 in New York City to further review and discuss the outcomes of the ORCA-1 trial. The Investor Day will start at 12PM ET and will be 2 hours in duration. This is an RSVP-only event open to members of the investment community. Additional details and registration information is available at the Achieve website, http://ir.achievelifesciences.com/events-and-webcasts.
Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com and www.orcaprogram.com.
Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking. Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.
As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.
ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the safety and effectiveness