Adial Pharmaceuticals Provides Update on ONWARD™ Phase 3 Pivotal Trial

Landmark Trial Addressing Global Interest in Reducing Alcohol Addiction

CHARLOTTESVILLE, VA / ACCESSWIRE / April 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial of its lead drug candidate, AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD).

"Adial expects to enroll 294 trial subjects for ONWARD™. To date, 30 trial subjects have been recruited and 8 of these subjects have satisfied trial screening criteria, including our companion genetic test, and patient dosing began in March," commented William Stilley, CEO of Adial Pharmaceuticals. "ONWARD™ is progressing during the COVID-19 pandemic with certain trial enhancements and modifications to move the trial forward diligently while reducing the potential exposure of trial subjects."

ONWARD™ has been adapted to incorporate the use of tele-medicine and has reduced in-clinic visits and non-essential procedures:

  • Site initiation visits are now being conducted by video conference, and interim monitoring visits will also be conducted by video conference.
  • The number of in-clinic visits per subject has been reduced from 19 to 8.
  • Five in-clinic visits per subject have been replaced with tele-medicine safety and efficacy assessments and behavioral treatments.
  • The duration of in-clinic visits has been shortened by eliminating non-essential procedures.
  • Changes are not expected to negatively impact ONWARD™ reaching its primary end-points.
  • Adial expects these changes to increase ONWARD™ subject retention rates due to the reduced in-person attendance requirements and to mitigate the placebo effect in the trial due to fewer in-person counseling sessions, both of which would be expected to enhance the statistical strength of the trial.

Regulatory approvals to commence ONWARD™ have been received for a number of countries. In order to commence the trial in each country, approval must be received by the country's Central Authority (CA) and Ethics Committee (EC). The term "on hold" pertains to COVID-19 regulations or precautions.

Country

CA Status

EC Status

Notes

Finland

Approved

Approved

6 sites expected

  • 2 sites activated (1 fully; 1 continuing with current patients but with further recruiting on hold)
  • 4 sites on hold

Bulgaria

Approved

Approved

6 sites expected

  • 3 sites continuing (2 activated by video conference; 1 pending video conference activation)
  • 3 sites located in hospitals on hold

Estonia

Approved

Approved

3 sites expected

  • Site initiations on hold

Latvia

Approved

Approved

3 sites expected

  • Site initiations on hold

Sweden

Approved

Expected

May 2020

1 site expected

  • Plan to initiate site by video conference

Poland

On Hold

Approved

3 sites expected

  • Non-COVID-19 CA reviews temporarily suspended

Croatia

On Hold

Approved

3 sites expected

  • Non-COVID-19 CA reviews temporarily suspended

Mr. Stilley concluded, "Even though the COVID-19 related delays are expected to extend the time to receive trial data by several weeks, we are making steady progress, and more than 25% of trial subjects screened to date have been qualified, exceeding our projections. Additionally, our cash burn has been reduced as a result of the changes. We continue to carefully manage our expenses, and remain confident we can complete the ONWARD™ trial without raising additional dilutive financing."

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 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. 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 Adial's plan to enroll 294 trial subjects for ONWARD, the changes increasing subject retention due to by reduced in-person attendance requirements and mitigating the placebo effect due to fewer in-person counseling sessions, both of which would enhance the statistical strength of the trial, COVID-19 related delays extending the time to receive trial data by several weeks, completing the ONWARD™ trial without raising additional dilutive financing, 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 continue enrollment during the COVID-19 pandemic, our ability to increase retention by reduced in-person attendance requirements and mitigate the placebo effect due to fewer in-person counseling sessions, our ability to mitigate COVID-19 related delays extending the time to receive trial data, our ability to enhance the statistical strength of the trial, our ability to complete the ONWARD™ trial without raising additional dilutive financing, our ability to expand the use of AD04 for use in patients with opioid use disorder, gambling and obesity, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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: dwaldman@crescendo-ir.com

SOURCE: Adial Pharmaceutical, Inc.



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