A randomized placebo-controlled clinical trial of cytisinicline for nicotine e-cigarette cessation

Topline Data Results Reported in Q2′2023

ORCA-V1 was a Phase 2 trial designed to evaluate the efficacy and safety of 3mg cytisinicline dosed 3 times daily for a period of 12-weeks compared to placebo in 160 adult users of nicotine e-cigarettes or vapes. All subjects received behavioral support for the duration of the trial.

DATA RESULTS

The primary endpoint for ORCA-V1 was biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Cytisinicline treatment demonstrated a significantly significant better quit rate than placebo with an odds ratio of 2.64.

• Subjects who received 12 weeks of cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping during the last 4 weeks of treatment compared to subjects who received placebo (p=0.035). The abstinence rate during weeks 9-12 was 31.8% for cytisinicline compared to 15.1% for placebo.

DESIGN

A total of 160 subjects were randomly assigned to one of two arms:

1. Arm A, 12 weeks placebo + behavior support: N=53
2. Arm B, 12 weeks of cytisinicline + behavior support: N=107