Company: ACHV
Filing Date: 2025-03-11
Form Type: 10-K
Source: 0000950170-25-036831
Chunk: 21

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-03-11
Form: 10-K
Item: Item 1
Chunk 21
---
3 mg cytisinicline TID were five times more likely to stop smoking compared to smokers receiving placebo.

At week 4, all four cytisinicline arms also demonstrated statistically significant (p<0.05) reductions in expired carbon monoxide, or CO, a biochemical measure of smoking activity. Expired CO levels had declined by a median of 71-80% in the cytisinicline treatment arms, compared to only 38% in the placebo arms. 

Cytisinicline was well-tolerated with no SAEs reported. The most commonly reported (>5%) adverse events, or AEs, across all cytisinicline treatment arms versus placebo arms were abnormal dreams, insomnia, upper respiratory tract infections, and nausea. In the 3 mg TID treatment arm versus placebo arms, the most common AEs were abnormal dreams, insomnia, and constipation (each 6% vs 2%), upper respiratory tract infections (6% vs 14%), and nausea (6% vs 10%), respectively. Compliance with study treatment was greater than 94% across all arms.  

9

A summary of AEs reported in subjects in the ORCA-1 trial is included in the table below. 

    TID
    Declining Titration
    Pooled

    1.5 mg(n=52)
    3.0 mg(n=50)
    1.5 mg(n=51)
    3.0 mg(n=50)
    Cytisinicline(n=203)
    Placebo(n=51)

    At least 1 AE
    20 (39%)
    21 (42%)
    29 (57%)
    23 (46%)
    93 (46%)
    24 (47%)

    URTI
     5 (10%)
    3 (6%)
    3 (6%)
    2 (4%)
    13 (6%)
    7 (14%)

    Abnormal dreams
    4 (8%)
    3 (6%)
    4 (8%)
    7 (14%)
    18 (9%)
    1 (2%)

    Nausea
    1 (2%)
    3 (6%)
    5 (10%)
    3 (6%)
    12 (6%)
    5 (10%)

    Insomnia