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Achieve Life Sciences has initiated the ORCA-OL clinical trial to evaluate the long-term safety of cytisinicline, a treatment for smoking and nicotine dependence. The open-label trial involves 29 U.S. sites and aims to collect data required for a New Drug Application (NDA) submission expected in the first half of 2025. The study will focus on adults who smoke or use nicotine e-cigarettes, engaging prior ORCA trial participants. It will collect long-term safety data from at least 300 subjects over six months and 100 subjects over one year. Achieve aims to address the FDA's lack of approved treatments for vaping cessation.
Achieve Life Sciences (Nasdaq: ACHV) announced that data from their Phase 2 ORCA-V1 trial will be presented at the Society of General Internal Medicine (SGIM) Annual Meeting in Boston on May 17, 2024. The study, led by Dr. Nancy Rigotti of Harvard Medical School, demonstrated that cytisinicline treatment more than doubled the likelihood of quitting nicotine e-cigarettes compared to placebo. Dr. Rigotti's presentation will occur at 2:45 PM EDT during the 'SAN2: Scientific Abstract Oral Presentations in Mental/Behavioral Health and Substance Use' session. The study was supported by the NIH's National Institute on Drug Abuse.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) reported Q1 2024 financial results, highlighted by positive Phase 2 trial results for cytisinicline in vaping cessation published in JAMA IM, plans to initiate a long-term safety exposure trial, and successful presentations at medical conferences. The company also secured approximately $124.2 million in equity financing to support ongoing clinical development activities. Achieve's cash position stood at $66.4 million as of March 31, 2024, with total operating expenses at $6.0 million and a net loss of $6.5 million for the quarter.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced the publication of ORCA-V1 trial results in JAMA Internal Medicine. The trial showed that treatment with cytisinicline more than doubled the odds of quitting e-cigarettes compared with placebo, with excellent compliance and safety. Achieve plans to conduct an End-of-Phase 2 Meeting with the FDA to discuss Phase 3 trial plans.
