On November 12, 2020 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 2020 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, NOV 12, 2020, View Source [SID1234570790]).
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Recent Events & Highlights
Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States
Promoted John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President
Presented successful results from the RAUORA, head-to-head non-inferiority clinical trial comparing cytisinicline and Chantix (varenicline), at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting
Presented mechanism of action data comparing 5-HT3 receptor activity of cytisinicline vs. Chantix at SRNT-E, providing rationale for differentiated side effect profile of smoking cessation treatments
Announced smoking cessation Key Opinion Leader Virtual Roundtable to be held on November 17, 2020
"With the initiation of the Phase 3 ORCA-2 trial and the breakthrough evidence, both mechanistically and clinically, in support of cytisinicline in comparison to Chantix, the third quarter of 2020 has undeniably been the most pivotal in the history of our company," commented John Bencich, Chief Executive Officer of Achieve. "Our primary focus in the coming months will be enrollment and execution of ORCA-2, while continuing to explore opportunities for commercialization and expansion into new therapeutic indications, digital health technologies, and audiences who may benefit from cytisinicline, specifically, users of vapes or e-cigarettes."
Phase 3 ORCA-2 Trial Initiation
Achieve’s first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo.
Management Team Update
In September, the Company announced the promotion of John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President. Mr. Bencich has been serving as Achieve’s Chief Financial and Operating Officer since 2017 and will join the Board of Directors in his role. Dr. Jacobs has been serving as the Chief Medical Officer of Achieve since 2017 and will continue in her role leading the regulatory and clinical development efforts for cytisinicline. Rick Stewart will remain with Achieve as the Executive Chairman of the Board of Directors and Dr. Anthony Clark will remain in his role as Chief Scientific Officer.
RAUORA: Significantly Fewer Adverse Events and Higher Quits Rates for Cytisinicline vs Chantix
Final results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix) in Māori (indigenous New Zealanders) and whānau (family) of Māori were presented at the SRNT-E Annual Meeting in September 2020. Results showed that cytisinicline met the pre-specified non-inferiority endpoint and was trending towards superiority demonstrating a 4.29% improvement in quit rates in favor of cytisinicline. Subjects in the cytisinicline arm were approximately one and a half times more likely to have quit smoking at 6 months compared to subjects who received varenicline. Importantly, significantly fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects. Of the subjects who experienced AEs (111 in the cytisinicline arm compared to 138 in the varenicline arm), there was significantly less nausea and vivid dreams.
MOA Data Explaining Reduced Nausea and Vomiting with Cytisinicline Presented at SRNT-E
Data presented at the SRNT-E Annual Meeting in September 2020 provides a rationale based on detailed receptor pharmacology to explain why the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with Chantix. The preclinical study, conducted at the University of Cambridge Department of Biochemistry, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT3 receptor. The study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline.
Virtual Smoking Cessation KOL Roundtable to be Held November 17, 2020
Achieve announced plans to host a virtual roundtable on cytisinicline and smoking cessation on Tuesday, November 17, 2020, at 12:00PM EST. Five esteemed experts in the field of smoking cessation will discuss the ongoing ORCA-2 trial, review recent cytisinicline data, and discuss the importance of smoking cessation in the midst of the COVID-19 pandemic. Visit View Source for additional information and click here to register for the event.
Financial Results
As of September 30, 2020, the company’s cash, cash equivalents, and restricted cash was $22.4 million. Total operating expenses for the three and nine months ended September 30, 2020 were $3.8 million and $10.0 million, respectively. Total net loss for the three and nine months ended September 30, 2020 was $3.8 million and $10.0 million, respectively.
As of November 12, 2020, Achieve had 3,617,664 shares outstanding.
Conference Call Details
Achieve will host a conference call at 4:30pm Eastern time today, Thursday, November 12, 2020. 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 8047128. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.