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Clinical Trials

//Clinical Trials
Clinical Trials2019-10-29T21:49:55-05:00

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.

Data Results

Quit Rates

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  • 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
(N=50)
Placebo
(N=51)
P Value
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
  1. Average % reduction expired CO from Baseline by Day 26
  2. Biochemically confirmed quit on Day 26 (no cigarettes smoked and expired CO<10 ppm)
  3. Biochemically confirmed  on Day 26 and weeks 5, 6, 7, & 8 (no cigarettes smoked and expired CO<10 ppm)

Safety

Most commonly reported (>5%) side effects from ORCA-1:

Adverse Event 3.0 mg TID
(N=50)
Pooled Cytisinicline
(N=203)
Placebo
(N=51)
At least 1 AE 46% 46% 47%
Upper Respiratory Tract Infections 6% 6% 14%
Nausea 6% 6% 10%
Abnormal Dreams 6% 9% 2%
Insomnia 6% 7% 2%
Constipation 6% 2% 2%
Headache 2% 5% 2%
  • Cytisinicline was well-tolerated across all treatment groups
  • Overall low incidence of adverse events
  • No serious or severe adverse events reported

Study Design

Objective:

  • 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

Population:

  • Smokers of ≥10 cigarettes/day and expired air CO > 10 ppm

Endpoints:

  • Biochemically verified abstinence
  • Reduction in self reported cigarettes smoked during treatment
Study Design

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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 late-2019.

ORCA Program

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