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Ongoing Research of Cytisinicline for Addiction

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial of Cytisinicline in Adult Smokers

Topline Data Results Reported in Q2′2022

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To learn more about the ORCA program, visit www.OrcaProgram.com–>

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)

Adverse Events Placebo
(N=270)
6-week CYT
(N=269)
12-week CYT
(N=270)
At least 1 TEAE 166 (61.5%) 172 (63.9%) 184 (68.1%)
Insomnia 13 (4.8%) 23 (8.6%) 26 (9.6%)
Abnormal Dreams 8 (3.0%) 22 (8.2%) 21 (7.8%)
Headaches 22 (8.1%) 18 (6.7%) 21 (7.8%)
Nausea 20 (7.4%) 16 (5.9%) 15 (5.6%)

 

Low rates of AEs compare favorably to currently approved smoking cessation products.

Design

The ORCA-2 Trial evaluated the safety and efficacy of 3mg cytisinicline dosed three times daily for 6 and 12 weeks compared to placebo.

  • Placebo-controlled & double-blind
  • Three 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: four-week continuous abstinence ON treatment
  • Follow up to six months