Presentation Schedule and Highlights
March 21, 2024 ,11:30 AM GMT : Achieve’s Director of Clinical Operations,Roxann Becco , will present patient-reported outcomes from the Phase 3 ORCA-2 and ORCA-3 clinical trials. Data collected include trial participants’ experiences, such as cravings and withdrawal symptoms, personal impact on overall health, and opinions on future use.March 22, 2024 ,8:30 AM GMT : Achieve’s Chief Medical Officer and President, Dr.Cindy Jacobs , will present data from the second, completed Phase 3 ORCA-3 trial that evaluated the efficacy and safety of cytisinicline in 792 adult smokers inthe United States . Findings confirmed results from the previous Phase 3 ORCA-2 trial demonstrating that cytisinicline, when dosed at the 3mg, three times daily schedule for either 6 or 12 weeks, increased smoking abstinence when compared with placebo and was very well-tolerated with no treatment-related serious adverse events reported.March 23, 2024 ,9:45 AM GMT : Dr.Nancy Rigotti , ORCA-V1 Principal Investigator and Professor of Medicine atHarvard Medical School and Director ofTobacco Research and Treatment Center ,Massachusetts General Hospital , will present data from the Phase 2 ORCA-V1 trial. ORCA-V1 evaluated the effectiveness and safety of cytisinicline in users of nicotine e-cigaretteswho wanted to quit vaping. Similar to the efficacy and tolerability findings observed in the combustible cigarette cessation Phase 3 trials, ORCA-V1 participantswho received cytisinicline had increased successful vaping cessation rates, compared with placebo, and reported minimal rates of adverse events.
“We are appreciative of this opportunity at the SRNT Annual Meeting to share multiple data presentations that reflect the promising results we have seen in the cytisinicline ORCA program for both smoking and vaping cessation,” stated Dr.
For additional information on the cytisinicline presentations and the
ORCA-V1 is supported by the
About Achieve and Cytisinicline
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in
In addition, there are over 11 million adults in
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic conditions, including inflation, rising interest rates, instability in the global banking sector, and public health crises, such as the COVID-19 pandemic, and the other factors described in the risk factors set forth in Achieve’s filings with the
Investor Relations Contact
achv@cg.capital
(404) 736-3838
Media Contact
Glenn.Silver@Finnpartners.com
(646) 871-8485
References
1Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults –
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4Birdsey J, Cornelius M, Jamal A, et al.
Source:
2024 GlobeNewswire, Inc., source