The ORCA-1 Phase 2b Dose Optimization Trial evaluated the efficacy, safety, and tolerability of cytisinicline as an aid to smoking cessation in 254 smokers in the United States.
- Statistically significant quit rates demonstrated at both end of treatment and weeks 5 through 8 (the FDA approvable endpoint)
- Adherence to study treatment was 98% in the 3.0 mg TID arm
- Cytisinicline was well-tolerated with no serious adverse events reported
- 3.0 mg dose with TID administration selected to move forward to Phase 3 development
|Characteristic||3.0 mg CYT
|Reduction in Expired CO1||80%||38%||p = 0.003|
|4 Week Abstinence2||54%||16%||p < 0.001|
|Continuous Abstinence (Weeks 5-8)3||30%||8%||p = 0.005|
- Average % reduction expired CO from Baseline by Day 26
- Biochemically confirmed quit on Day 26 (no cigarettes smoked and expired CO<10 ppm)
- Biochemically confirmed on Day 26 and weeks 5, 6, 7, & 8 (no cigarettes smoked and expired CO<10 ppm)
Most commonly reported (>5%) side effects from ORCA-1:
|Adverse Event||3.0 mg TID
|At least 1 AE||46%||46%||47%|
|Upper Respiratory Tract Infections||6%||6%||14%|
- Cytisinicline was well-tolerated across all treatment groups
- Overall low incidence of adverse events
- No serious or severe adverse events reported
- To optimize Phase 3 trial planning for dosing, scheduling, compliance and efficacy rates in U.S.
- Evaluate safety and efficacy of 1.5mg and 3mg of cytisinicline vs placebo administered over 25 days
- All subjects to receive standardized behavioral support and will be followed up out to 8 weeks
- Smokers of ≥10 cigarettes/day and expired air CO > 10 ppm
- Biochemically verified abstinence
- Reduction in self reported cigarettes smoked during treatment
Phase 3 trials
The Company plans to initiate the U.S. Phase 3 development program in 2020, subject to the availability of capital.
It is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction, including approximately 2,000 patients in Phase 3 clinical trials conducted in Europe and New Zealand and published in the New England Journal of Medicine. The United States cytisinicline Phase 3 development program is expected to initiate in 2020.
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