Adial Pharmaceuticals Announces Modifications to the Phase 3 Pivotal Trial of AD04 to Protect Subjects from COVID-19
CHARLOTTESVILLE, VA / ACCESSWIRE / March 17, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that, effective immediately, the Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients. In order to better protect subjects enrolled in the Phase 3 clinical trial during the COVID-19 pandemic, the Company is in the process of modifying its protocol to reduce the number of in-person visits to clinical sites and replace certain visits with tele-medicine behavioral treatments and assessments. In addition, the duration of in-person visits is being reduced through the removal of non-essential assessments. European regulators have encouraged sponsors of clinical trials to take action to reduce travel and potential exposure of study subjects and have indicated receptivity to modifications that achieve this end.
"As always, the safety of our study participants is our first priority, and we believe it is prudent to reduce the potential exposure of participants in the Phase 3 trial of AD04 to COVID-19," stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "Our expectation is that the changes being implemented will not affect the quality or outcome of the trial. In fact, we believe the adjustments may increase retention rates due to the in-person visit schedule being less onerous, which may materially benefit the trial by increasing statistical power. It is also our expectation that the modified visit schedule will reduce trial costs since expenses related to in-person visits will be reduced."
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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 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 the changes to the protocol better protecting subjects enrolled in the Phase 3 clinical trial, increasing retention rates due to the in-person visit schedule being less onerous, which may materially benefit the trial by increasing statistical power, the modified visit schedule reducing trial costs and the potential of AD04 to treat AUD and 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, the protocol changes having the desired effect of better protecting subjects enrolled in our Phase 3 clinical trial, increasing retention rates, increasing statistical power and reducing trial costs, our ability to commence the Phase 3 clinical trials as expected, the 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, 2018, 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.
Crescendo Communications, LLC
David Waldman / Natalya Rudman
SOURCE: Adial Pharmaceutical, Inc.
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Released March 17, 2020