SEATTLE, Wash. and VANCOUVER, British Columbia, Sept. 6, 2018 – – Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced that cytisine data will be presented at the Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Conference , September 6-8th in Munich, Germany.
The presentations include a review of cytisine’s safety profile and an overview of Achieve’s upcoming Phase 2b study, planned to initiate later this year. Both presentations will be included in the Pharmacotherapy poster session on Friday, Sept. 7th at 2pm local time.
“This conference provides an excellent opportunity to update the scientific community on the progress we continue to make in advancing the global availability of cytisine,” commented Dr. Cindy Jacobs, MD, PhD, Chief Medical Officer of Achieve. “Our Phase 2b trial, scheduled to commence in the coming months, will further clarify the optimal cytisine dosing schedule and compliance measures to inform our development plans going forward.”
Two, investigator-sponsored Phase 3 clinical trials of cytisine were successfully completed in over 2,000 patients. The TASC Phase 3 trial was a 740 patient, double-blind placebo controlled trial conducted by University College London. The CASCAID trial was a 1,310 patient, single-blind trial comparing cytisine to nicotine replacement therapy. Both trials were published in the New England Journal of Medicine in December 2011 and December 2014 respectively. Achieve is working closely with the smoking cessation community and regulatory agencies to advance the global availability of cytisine.
About Achieve & Cytisine
Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisine. Tobacco use is currently the leading cause of preventable death and is responsible for nearly six million deaths annually worldwide1. It is estimated that 28.6% of all cancer deaths in the U.S. are attributable to cigarette smoking2.
Cytisine is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. Two prior, large-scale Phase 3 clinical studies of cytisine, with favorable outcomes, have been successfully completed in over 2,000 patients. The TASC trial was a 740 patient, double-blind, placebo controlled trial conceived by Professor Robert West at University College London and funded by the U.K. National Prevention Research Initiative. The CASCAID trial was a 1,310 patient, single-blind, non-inferiority trial comparing cytisine to nicotine replacement therapy (NRT). The CASCAID trial was conceived by Dr. Natalie Walker, National Institute for Health Innovation, University of Auckland and funded by the Health Research Council of New Zealand. Both trials were published in the New England Journal of Medicine.
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 cytisine clinical development activities, the potential market size for cytisine and the potential benefits of cytisine. 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 cytisine 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 cytisine; the risk that cytisine 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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1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2011, Geneva: World Health Organization, 2011.
2Annals of Epidemiology , Volume 25 , Issue 3 , 179 – 182.e1