Adial Pharmaceuticals Reaches 35% Enrollment in ONWARD(TM) Pivotal Phase 3 Trial of AD04 for the Treatment of Alcohol Use Disorder

Rhea-AI Summary

Adial Pharmaceuticals announced reaching a 35% enrollment milestone in its ONWARD™ Phase 3 trial, evaluating the efficacy of its drug candidate AD04 for treating Alcohol Use Disorder (AUD) in Europe. The company anticipates hitting 50% enrollment shortly, aided by a decrease in early termination rates and no reported serious adverse events. Amid the COVID-19 pandemic, adjustments have been made for remote participation. The urgent need for effective AUD treatments has intensified due to increased alcohol issues during lockdowns.

Positive

• 35% enrollment achieved in ONWARD™ Phase 3 trial.
• Anticipated 50% enrollment soon.
• Lower than expected early termination rates.
• No serious adverse events reported.
• Protocol adjustments made for remote participation.

Negative

• None.

ONWARD™ Trial Remains on Track to be Fully Enrolled During Q2 2021

CHARLOTTESVILLE, VA / ACCESSWIRE / December 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced it has reached the 35% enrollment target in the Company's landmark ONWARD™ Phase 3 pivotal trial in Europe. ONWARD™ is investigating the efficacy and safety of Adial's lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes.

William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "Reaching the 35% enrollment target reaffirms the continued progress in our ONWARD™ Phase 3 trial in Europe. Additionally, there has been an uptick in screenings, and, based on our enrollment rates to date, we anticipate having the ONWARD trial 50% enrolled in the next month. We are encouraged that the early termination rate is lower than we had expected. Importantly, there have been no serious adverse events to date. We are also adding additional sites in high enrolling countries, which we believe will further enhance the trial enrollment. In response to the COVID-19 pandemic, a protocol amendment was successfully implemented at all sites to incorporate remote procedures and reduce clinical trial participant time on site. As a result, we remain on track to complete enrollment by the second quarter of 2021 and look forward to providing further updates as we advance the trial."

"We are especially proud to achieve these milestones on schedule, despite the impact of COVID-19 on clinical trials around the globe, and we remain fully committed to advancing our goal of bringing this meaningful new treatment for AUD to patients worldwide. Today, there is no adequate treatment for AUD as current therapies have limited efficacy and significant side effects. It is widely reported that the alcohol problem has grown worse during the COVID-19 lockdown, heightening the urgency for pharmacological interventions such as AD04."

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 Pivotal Clinical Trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be 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. 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 having the ONWARD trial 50% enrolled in the next month, additional sites in high enrolling countries further enhancing the trial enrollment, remaining on track to complete enrollment by the second quarter of 2021 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, our ability to enroll patients within the timelines anticipated and complete clinical trials on time and 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 its 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, 2019, 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

SOURCE: Adial Pharmaceutical, Inc.

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FAQ

What is the ONWARD™ trial by Adial Pharmaceuticals?

The ONWARD™ trial is a Phase 3 clinical study evaluating the efficacy and safety of Adial's drug candidate AD04 for treating Alcohol Use Disorder (AUD).

When is the ONWARD™ trial expected to be fully enrolled?

Adial Pharmaceuticals expects the ONWARD™ trial to be fully enrolled by the second quarter of 2021.

What milestone did Adial Pharmaceuticals recently reach in its clinical trial?

Adial Pharmaceuticals reached a 35% enrollment milestone in its ONWARD™ Phase 3 trial as of December 2020.

What are the potential implications of the ONWARD™ trial results?

The results of the ONWARD™ trial could lead to a new treatment option for Alcohol Use Disorder, addressing the growing demand for effective therapies.

What is the significance of Adial's drug candidate AD04?

AD04 is designed as a treatment for Alcohol Use Disorder (AUD), targeting specific genetic profiles, and aims to offer a pharmacological intervention amid rising alcohol consumption during the COVID-19 pandemic.