Achieve Life Sciences, Inc. issued the following announcement on July 23.
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company focused on nicotine addiction, today announced it has extended its strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). Under the extended collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical studies as requested by the U.S. Food and Drug Administration (FDA) to be included in the cytisinicline New Drug Application (NDA).
“Given the research results to date, we are extending our partnership with Achieve to aid in moving the science forward regarding this approach for smoking cessation,” said David Shurtleff, Ph.D., NCCIH Deputy Director. “Smoking continues to be the leading cause of preventable death around the world, and new treatment options have the potential to complement existing evidence-based cessation strategies.”
In discussions with the FDA in 2018, it was determined that a Good Laboratory Practice (GLP) non-clinical reproductive study would be required to support the NDA submission. NCCIH has agreed to sponsor this study which is expected to complete in 2020.
Previously under the collaboration, the NCCIH sponsored the GLP nonclinical studies that were required for the Investigational New Drug (IND) application in order to initiate clinical studies. These studies included genotoxicity testing, safety pharmacology, cardiac conduction studies, pharmacokinetics, toxicokinetics, and the required toxicology studies in two species. Combined fertility and developmental studies were also conducted and co-sponsored by the NCCIH and the National Cancer Institute (NCI) in preparation for initiating the Phase 3 development program. In total, the NIH has committed approximately $6 million dollars to the development of cytisinicline.
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