Achieve Life Sciences, a clinical-stage pharmaceutical company, 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.
According to a statement from the company, Achieve also 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 Cindy Jacobs, MD, and Nancy Rigotti, MD, professor of medicine at Harvard Medical School and director of the Tobacco Research and Treatment Center at Massachusetts General Hospital.
“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,” John Bencich, chief executive officer of Achieve, said in a press release. “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.