SEATTLE, Wash. and VANCOUVER, British Columbia, September 5, 2019 – – Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced the Company will host its first investor day on Friday, September 20, 2019 in New York City.
The event will include an updated data presentation by the primary investigator of the Phase 2b ORCA-1 trial of cytisinicline. It will also feature a panel discussion moderated by leading healthcare analysts, Michael Higgins from Ladenburg Thalmann and Jason McCarthy from Maxim Group, with participation from four esteemed medical experts in the field of smoking cessation.
In June of 2019, Achieve Life Sciences announced statistically significant, topline results from its 254-subject, Phase 2b ORCA-1 dose-selection trial of cytisinicline for smoking cessation. The outcome of the trial has led to the selection of 3.0 mg, three times daily (TID) dosing for future Phase 3 development. Cytisinicline treatment demonstrated significant improvements across all treatment arms in both reduction in cigarettes smoked and abstinence rates compared to placebo. The most impressive results were observed in the 3 mg TID treatment arm which demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005). Four week continuous abstinence is the relevant endpoint for regulatory approval.
The Investor Day will start at 12PM ET and will be 2 hours in duration. This is an RSVP-only event open to members of the investment community. Additional details and registration information is available at the Achieve website, http://ir.achievelifesciences.com/events-and-webcasts.
About Achieve Life Sciences
Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking.
Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.
As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.
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 planned cytisinicline clinical development activities, the timing of clinical development activities related to cytisinicline, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
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