Company: ACHV
Filing Date: 2025-03-11
Form Type: 10-K
Source: 0000950170-25-036831
Chunk: 22

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-03-11
Form: 10-K
Item: Item 1
Chunk 22
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    4 (8%)
    3 (6%)
    3 (6%)
    4 (8%)
    14 (7%)
    1 (2%)

    Headache
    6 (12%)
    2 (4%)
    1 (2%)
    1 (2%)
    10 (5%)
    2 (4%)

    Fatigue
    3 (6%) 
    1 (2%)
    1 (2%)
    2 (4%)
    7 (3%)
    2 (4%)

    Constipation
    1 (2%)
    3 (6%)
    0 (0%)
    0 (0%)
    4 (2%)
    1 (2%)

The outcome of the ORCA-1 trial was the selection of 3 mg TID for Phase 3 development. Overall, the 3 mg dose administered TID demonstrated the best overall safety and efficacy when compared to other doses and administrations studies in ORCA-1. The results from ORCA-1 study were published in the journal Nicotine and Tobacco Research in 2021.

Phase 2 ORCA-V1 Trial for E-cigarette (Vaping) Cessation

In June 2022, following NIDA/NIH review of completed regulatory and clinical operational milestones plus acceptance of the IND by the FDA, we announced that we were awarded the next grant funding from NIDA in the amount of approximately $2.5 million. The full grant award of $2.8 million covered approximately half of the total ORCA-V1 clinical study costs. The Primary Investigators for the grant were Dr. Cindy Jacobs, our President and Chief Medical Officer, and Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital.

In June 2022, we announced the initiation of the Phase 2 ORCA-V1 clinical trial. In April 2023, we reported positive topline results showing a statistically significant vaping cessation benefit for cytisinicline-treated participants in the ORCA-V1 trial. 

ORCA-V1 evaluated 160 adults who used e-cigarettes on a daily basis at five clinical trial locations in the United States. ORCA-V1 participants were randomized to receive 3 mg cytisinicline three times daily or placebo for 12 weeks in combination with standard cessation behavioral