ORCA-1

ORCA-2 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 in 810 adult smokers (randomized 1:1:1). Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial.

Data Results

The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Both the 6- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo with odds ratios of 8.0 and 6.3, respectively.

  • Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.

  • Subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 3-6 was 25.3% for cytisinicline compared to 4.4% for placebo.

Safety Profile

  • Well-tolerated with single digit rates of adverse events (AEs)

  • No treatment-related serious adverse events reported

Most commonly reported AEs (>5% Overall)

Low rates of AEs compares favorably to currently approved smoking cessation products

Design

  • Placebo-controlled & double-blind
  • 3 treatment arms: Placebo vs 6 or 12 weeks cytisinicline
  • Cytisinicline treatment for 6 or 12 weeks

    • Does longer treatment lead to better efficacy?
    • Does continued treatment prevent early relapses?
  • Primary Endpoint: 4-week continuous abstinence ON treatment
  • Follow up to 6 months
ORCA-2 Schematic

ORCA-2 Trial Locations

ORCA-2 was conducted at the following locations in the US.

AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY DC

Atlanta Clinical Research

The General Hospital Coporation
d/b/a Massachusetts General Hospital

FutureSearch Trials of Dallas

MediSphere Medical Research Center, LLC

Alliance for Multispecialty Research (CPR)

Alliance for Multispecialty Research
(Volunteer Research Group)

Alliance for Multispecialty Research
(AMR Las Vegas)
Alliance for Multispecialty Research
(Central Kentucky Research)
Alliance for Multispecialty Research
(Clinical Research of South Florida)
Alliance for Multispecialty Research
(Coastal Clinical Research)

Coastal Carolina Research

Alliance for Multispecialty Research
(New Orleans Center for Clinical Research)

Alliance for Multispecialty Research
(Tidewater Clinical Research Associates)

Arizona State University

M3 Wake Research, Inc.

Rochester Clinical Research

Alliance for Multispecialty Research
(Heartland Research)