On November 9, 2021 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, reported third quarter 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, NOV 9, 2021, View Source [SID1234594990]).
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Recent Highlights
Provided an update on the ORCA-2 Phase 3 clinical trial, including announcing that all subjects have completed the treatment portion of the study and are in follow-up, and that topline data is expected in the first half of 2022
Discussed ongoing planning activities for ORCA-3, the second Phase 3 clinical trial supporting cytisinicline regulatory submission in the United States, which Achieve anticipates could launch by early 2022
Announced FDA acceptance of IND application for the evaluation of cytisinicline in nicotine e-cigarette cessation
Issued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimen
Presented cytisinicline data at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) annual meeting
Announced expansion of cytisinicline clinical operations team
"It has been another successful quarter as we continue to focus on meeting our key development milestones, specifically, completing the Phase 3 ORCA-2 trial, and preparing for the initiation of two new cytisinicline trials," commented John Bencich, Chief Executive Office of Achieve. "We are looking forward to an exciting year ahead with the expected ORCA-2 Phase 3 data results, the start of our second Phase 3 study in cigarette smoking cessation and launch of the grant-funded ORCA-V1 trial in e-cigarette cessation."
Ongoing ORCA-2 Phase 3 Clinical Trial
Achieve provided an update on the cytisinicline development program in adult cigarette smokers in the United States. The ORCA-2 Phase 3 trial completed enrollment of 810 subjects. To date, all subjects have completed study treatment and are currently in follow-up. The last subject is expected to complete their final visit by the end of 2021, with topline data expected to be announced in the first half of 2022.
Planned ORCA-3 Phase 3 Clinical Trial
Achieve reviewed ORCA-3 planning activities and announced that it has completed selection of a Contract Research Organization (CRO), finalized cytisinicline packaging and drug supply, and is currently undergoing clinical trial site selection. The trial is expected to initiate enrollment of approximately 750 adult cigarette smokers by early 2022.
FDA Acceptance of IND for Study of Cytisinicline in e-Cigarette Cessation
Achieve announced that the U.S. Food and Drug Administration (FDA) has completed their review and accepted an Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users in the United States and is expected to initiate in the second quarter of 2022. Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Completion of required milestones for the first phase of grant funding included the submission of the IND and clearance to proceed with the clinical trial by FDA.
Patents Issued for 3.0 mg TID Dosing Regimen
The U.S. Patent and Trademark Office issued U.S. Patent No. 11,083,715 and U.S. Patent No. 11,083,716 covering the novel 3.0 mg TID cytisinicline dosing regimen. Not including any patent term extensions to which Achieve may be entitled, the newly issued patents will expire in the third quarter of 2040. Upon approval of cytisinicline by the FDA, Achieve anticipates these patents would be included in the FDA’s Orange Book, which lists approved drugs and related patent and exclusivity information.
Cytisinicline Data Presented at SRNT-E Annual Meeting
Two cytisinicline data presentations were included in the SRNT-E annual meeting, held in September 2021. An analysis from the ORCA-1 trial found that subjects who previously failed to quit smoking with Chantix (varenicline) experienced a Week 4 abstinence rate of 51.3% upon treatment with cytisinicline using the three times daily (TID) regimen, compared with 15.8% with placebo (p= 0.009). An additional analysis, also from the ORCA-1 trial, found that smokers treated in the study with cytisinicline showed an earlier onset of sustained abstinence compared with placebo. Smokers who received the cytisinicline 3 mg TID had the shortest time to sustained smoking abstinence with a median of only 7 days of treatment compared to 18 days for placebo.
Expanded Clinical Operations Team
Achieve announced the expansion of its clinical operations team to include a Senior Director of Biometrics, Senior Manager of Clinical Trials, and Director of Clinical Operations, to support efforts with the ongoing and planned cytisinicline development program.
Financial Results
As of September 30, 2021, Achieve’s cash equivalents, and restricted cash was $33.4 million. Total operating expenses for the three and nine months ended September 30, 2021 were $6.7 million and $26.0 million, respectively. Total net loss for the three and nine months ended September 30, 2021 was $6.7 million and $26.0 million, respectively.
As of November 9, 2021, Achieve had 9,453,542 shares outstanding.
Conference Call Details
Achieve will host a conference call at 4:30pm Eastern time today, Tuesday, November 9, 2021. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 7997636. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.