Business
Achieve Life Sciences Awarded Grant from the National Institutes of Health to Conduct Phase 2 Trial of Cytisinicline in Nicotine e-cigarette Users
Company awarded $2.5 million to enable initiation of the Phase 2 ORCA-V1 clinical trial SEATTLE and VANCOUVER, British Columbia, June 01, 2022 (GLOBE
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Company awarded $2.5 million to enable initiation of the Phase 2 ORCA-V1 clinical trial\nSEATTLE and VANCOUVER, British Columbia, June 01, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that it has been awarded $2.5 million in grant funding 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 grant award will provide funding that enables Achieve to initiate the Phase 2 ORCA-V1 clinical trial, which aims to evaluate the efficacy and safety of cytisinicline in approximately 150 adult nicotine e-cigarette users at 5 clinical trial locations in the United States. Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director of the Tobacco Research and Treatment Center at Massachusetts General Hospital, will be the Principal Investigator of the trial. “We are grateful for the continued partnership with the NIH that has provided Achieve with non-dilutive funding that allows us to proceed with ORCA-V1 trial initiation in the coming weeks,” commented John Bencich, Chief Executive Officer of Achieve. “Cytisinicline’s efficacy and tolerability observed in clinical trials to date demonstrates its potential to help nicotine-dependent people overcome their addiction. With more than 10 million users of nicotine e-cigarettes in the United States alone, and no FDA-approved treatments available specifically for this indication, we believe cytisinicline has the ability to help meet the needs of this growing and underserved population.” In July 2021, an initial grant award of $320,000 was provided to Achieve to complete critical regulatory and clinical operational activities, including submission of a new IND to FDA for investigating cytisinicline in nicotine e-cigarette users. In total, $2.8 million has now been awarded under both the initial and current grant awards from the NIH and is expected to cover approximately half of the ORCA-V1 trial costs. The use of e-cigarettes continues to be widespread, with the most recent reports from the Centers for Disease Control and Prevention indicating ...