SEATTLE, Wash. and VANCOUVER, British Columbia, October 24, 2019 — 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 that data from the Phase 2b ORCA-1 trial will be presented at the SRNT-O Inaugural Conference.
“Successful Smoking Abstinence with Cytisinicline in the ORCA-1 Trial: What Happens Next?” will be presented at the SRNT-O meeting by Achieve’s Chief Scientific Officer, Dr. Anthony Clarke, on Friday, October 25th in Sydney. The results of the ORCA-1 trial, to be discussed in the presentation, confirm that future Phase 3 clinical trials are expected to utilize 3.0 mg TID dosing of cytisinicline. The Company plans to extend dosing in the Phase 3 trials from 25 days to 42 days, or six weeks. The slightly longer dosing will allow for the primary endpoint of continuous abstinence over 4 weeks to be measured while subjects are still on treatment and potentially improve quit rates.
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 earlier this year, demonstrated a 54% abstinence rate at week 4 in the 3.0 mg three times daily (TID) cytisinicline arm compared to 16% for placebo (p < 0.0001). Additionally for the 3.0 mg TID cytisinicline arm, a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was observed compared to 8% for placebo (p= 0.005). Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval.
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.
The Company plans to initiate the Phase 3 development program in 2020, subject to the availability of capital. Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.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 th