SEATTLE, Wash and VANCOUVER, British Columbia, March 14, 2019 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today provided an update on the cytisinicline clinical development program and announced fourth quarter and year-end 2018 financial results.
- Completion of enrollment in 254-subject Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers
- Presented final data from cytisinicline Phase 1/2 multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) study at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting
- Initiated a trial to assess the maximum tolerated dose, or MTD, for a single administered oral dose of cytisinicline
- Pediatric waiver agreed by the S. Food and Drug Administration (FDA)
- Closed registered direct offering for gross proceeds of $5.6 million
Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, “The cytisinicline development program continues to advance rapidly and we are well-poised for continued success in 2019. As demonstrated by the swift enrollment in our Phase 2b trial, new treatments are desperately needed to help the millions of people who desire to quit smoking.”
ORCA-1 Phase 2b Trial Fully Enrolled
In February, Achieve announced completion of enrollment of 254 smokers in a Phase 2b trial evaluating cytisinicline in both the 1.5 mg and 3.0 mg doses on a declining titration schedule as well as three times daily dosing, both over 25 days. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 is being conducted at eight centers across the U.S. and results are expected in mid-2019.
PK/PD Study Results Demonstrating Impressive Smoking Cessation Rates
The study evaluated the repeat-dose PK and PD effects of 1.5 mg and 3.0 mg cytisinicline in 26 healthy volunteer smokers when administered over the standard 25-day course of treatment. All subjects had a significant and immediate reduction in cigarettes smoked within 2 days of initiating cytisinicline treatment. By Day 26, subjects had an average 80% reduction in cigarettes smoked, 82% reduction in expired carbon monoxide (CO), and 46% had stopped smoking.
MTD Study Initiation
In March, Achieve initiated a trial to assess the MTD for a single administered oral dose of cytisinicline. This study will be performed in smokers who will receive one single dose of cytisinicline. The dosage of cytisinicline will be increased in separate groups of subjects per dose level until stopping criteria are reached, based on the occurrence of dose-limiting adverse events.
FDA Agrees to Full Waiver for Pediatric Population
FDA confirmed that they are in agreement with Initial Pediatric Study Plan, specifically, providing a full waiver for evaluating cytisinicline in a pediatric population. The reasons for the full waiver were based on the low numbers of children smoking under the age of 12 and the logistical difficulties of recruiting treatment-seeking smokers in the adolescent age group. The agreed Pediatric Study Plan will be included as part of Achieve’s future application for marketing approval of cytisinicline.
Completed $5.6M Financing
In October 2018, Achieve announced the closing of a registered direct offering that raised total gross proceeds of $5.6 million and after deducting approximately $0.6 million in placement agent fees and offering expenses, receiving net proceeds of $5.0 million.
As of December 31, 2018, the company’s cash, cash equivalents, short-term investments and restricted cash were $14.7 million. Total operating expenses for the fourth quarter and year ended December 31, 2018 were $3.7 million and $12.8 million, respectively. Total net