Adial Pharmaceuticals Provides Letter to Shareholders From CEO William Stilley
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the database lock for its ONWARD™ Phase 3 trial, which is crucial for evaluating the efficacy of AD04 in treating Alcohol Use Disorder (AUD). With data now set, professional statisticians will analyze the results, with top-line findings expected by mid-July 2022. The ONWARD trial involves patients genetically screened for specific polymorphisms and is pivotal for FDA approval of AD04. Adial emphasizes the importance of its research in addiction medicine, reflecting a strong commitment to advancing treatment options.
- Completion of database lock for ONWARD Phase 3 clinical trial.
- Anticipation of top-line results by mid-July 2022.
- AD04 demonstrated promising results in Phase 2b study for reducing alcohol consumption.
- Dependence on statistical analysis results for future FDA approval.
- Potential delays in announcing trial results could impact investor sentiment.
CHARLOTTESVILLE, Va., June 28, 2022 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), today issued the following letter to its shareholders from the Company’s CEO, William Stilley.
Dear Shareholders,
It continues to be my great honor to serve you as CEO of Adial Pharmaceuticals, especially at this momentous time when you and I, anxiously yet optimistically, await top-line results from the ONWARD™ Phase 3 clinical trial. Yesterday, we announced database lock for ONWARD, and today, I want to take this opportunity to personally write to you.
Great care was taken to verify and validate the integrity of all data collected during ONWARD, all of which remained blinded throughout. Now that database lock is complete, meaning the dataset has been permanently set, the data has been transferred to the Company´s outside, professional statisticians. At this point, only these statisticians have access to the unblinded ONWARD data, and they are now conducting their review.
When their analyses is complete, the statisticians will share the unblinded trial data and results with Adial. Adial will then review the unblinded data. In the next several weeks, and most likely by mid-July, we expect to publicly announce the top-line results. Following the announcement, Adial plans to further expand its review of the trial data to determine what other information may be useful to support an application for approval of AD04 to the FDA.
As Adial investors, we know the world needs a drug with the characteristics that AD04 demonstrated in the Phase 2b study. After more than three years of work and substantial investment, we seek to confirm and expand on the Phase 2b findings with revelation of the ONWARD results.
Nearly all of us have been impacted by alcohol addiction in some way. Precision medicine by genetic targeting could revolutionize the way addiction patients are perceived and treated. Adial is committed to advancing the science of addiction through medicine to achieve better outcomes.
Finally, thank you for your support. We could not have made it this far without you, and with you, we are advancing the battle against addiction.
Sincerely yours,
William Stilley, CEO
About the ONWARD™ Trial
The ONWARD Phase 3 clinical trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes. Patients were genetically screened prior to enrollment in ONWARD so that only genetically positive patients were enrolled. Approximately one-third of the screened patients tested genetically positive for the targeted genetics.
ONWARD was conducted in 25 clinical sites in six countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.
ONWARD is expected to serve as a basis for approval of AD04 for the treatment of Alcohol Use Disorder in patients identified as having the targeted genetics (i.e., a pivotal Phase 3 trial).
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company’s landmark ONWARD™ Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are identified using the Company’s proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. The Company is also developing adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adialpharma.com.
Forward Looking Statements
This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding publicly announcing the top-line results by mid-July, plans to further expand ours review of the trial data to determine what other information may be useful to support an application for approval of AD04 to the FDA, confirming and expanding on the Phase 2b findings with revelation of the ONWARD data, precision medicine by genetic targeting revolutionizing the way addiction patients are perceived and treated, the ONWARD trial serving as a basis for approval of AD04 for the treatment of Alcohol Use Disorder in patients identified as having the targeted genetics (i.e., a pivotal Phase 3 trial) and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to provide top-line results from the ONWARD™ Phase 3 clinical trial as planned, our ability to use the ONWARD trial as a basis for approval of AD04 for the treatment of Alcohol Use Disorder in patients identified as having the targeted genetics, our ability to enroll patients in future trials within the timelines anticipated and complete clinical trials on time, our ability to achieve desired results and benefits as expected, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2021, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Natalya Rudman
Tel: 212-671-1021
Email: adil@crescendo-ir.com
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