Achieve Life Sciences (ACHV) Awarded Grant from the National Institutes of Health (NIH) for the Evaluation of Cytisinicline in Cessation of Nicotine E-cigarette Use

July 22, 2021 9:38 AM EDT

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Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it has been awarded a grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) to evaluate the use of cytisinicline as a treatment for cessation of nicotine e-cigarette use.

This initial grant award, to commence on August 1, 2021, will be utilized to complete critical regulatory and clinical operational activities, such as protocol finalization, clinical trial site identification, and submission of a new IND to FDA for investigating cytisinicline in nicotine e-cigarette users. Upon completion of these milestones, as assessed by NIH, Achieve expects to receive the next stage of the grant award that will enable initiation of the Phase 2 ORCA-V1 clinical study evaluating cytisinicline in approximately 150 adult nicotine e-cigarette users in the United States. The Primary Investigators for the grant are Achieve's Chief Medical Officer, Dr. Cindy Jacobs, and Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital.

The use of e-cigarettes continues to be widespread, with most recent reports from the Centers for Disease Control and Prevention indicating that there were nearly 11 million adult users in the United States alone in 2019. While e-cigarettes have been historically viewed as less harmful than combustible cigarettes, their long-term safety remains controversial. In a recent study conducted by Achieve, where approximately 500 users of nicotine vaping devices or e-cigarettes were surveyed, approximately 73% of participants responded that they intend to quit vaping within the next 3 to 12 months. Of those who intended to quit even sooner, within the next 3 months, more than half stated they would be extremely likely to try a new prescription product to help them do so.

"This non-dilutive funding in partnership with the NIH enables us to evaluate the potential of cytisinicline to address nicotine addiction across a broader population," stated John Bencich, Chief Executive Officer of Achieve. "With the growing number of e-cigarette users and those who seek to quit, there is a significant unmet need for safe and effective treatments to aid in their success."

Achieve recently announced completion of enrollment in the Phase 3 ORCA-2 clinical trial, evaluating cytisinicline as a treatment for combustible cigarette cessation. Topline results from the ORCA-2 trial are expected in the first half of 2022. For more information on Achieve Life Sciences and cytisinicline please visit www.achievelifesciences.com.

The planned research and clinical study discussed in this press release is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) under Award Number R42DA054784. The content is the sole responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.



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