ADIL Adial Pharmaceuticals Inc

2.75
-0.38  -12%
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  1. CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has reached 50% enrollment in the Company's landmark ONWARD™ pivotal Phase 3 clinical trial. 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.

    "We are pleased to have achieved this important enrollment milestone in our ONWARD pivotal Phase 3 clinical trial," stated Schuyler Vinzant, Adial's Vice President of Development…

    CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has reached 50% enrollment in the Company's landmark ONWARD™ pivotal Phase 3 clinical trial. 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.

    "We are pleased to have achieved this important enrollment milestone in our ONWARD pivotal Phase 3 clinical trial," stated Schuyler Vinzant, Adial's Vice President of Development. "We have a high degree of confidence that ONWARD will be fully enrolled this summer."

    Data Points – ONWARD Trial Patients

    • 66% of planned patient screening visits completed
      • 830 patients screened out of 1,254 patients expected to be required to achieve full enrollment (more than 20 screened patients are currently pending enrollment)
    • 32% of patients screened are genetically positive for treatment with AD04
      • Percentage of genetically positive patients consistent with Phase 2b prevalence and expected U.S. and European prevalence
    • 75% of patients screened as genetically positive have been enrolled
      • Patient enrollment exceeds projected rate of 50% for genetically positive patients
    • 86% ONWARD™ patient retention rate to date
      • Retention rate significantly greater than projected 70% retention rate

    William Stilley, Adial's Chief Executive Officer, commenting on the ONWARD trial protocol, stated "Telephonic pre-screening of potential study patients has allowed us to successfully reduce non-genetic screen failure rates. Moreover, streamlined site visits and patient follow-up processes have resulted in better-than-expected retention rates to date."

    Mr. Stilley continued, "Adial would like to express its genuine gratitude to all the ONWARD patients for their participation in the study and appreciation for the commitment they have made. We also appreciate the hard work of the more than 50 incredible frontline healthcare workers, including doctors, nurses and their staff, who are caring for our patients and share Adial's commitment to improving outcomes for people suffering from Alcohol Use Disorder."

    About the Landmark ONWARD™ Pivotal Phase 3 Clinical Trial

    The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.

    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™ pivotal 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. 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 having the ONWARD™ trial fully enrolled this summer 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 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 our product candidates in the marketplace and the successful development, marketing or sale of our 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:



    Primary Logo

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  2. CHARLOTTESVILLE, Va., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be filing an application for "Fast Track" with the U.S. Food and Drug Administration (FDA) for its lead drug candidate, AD04, which is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes.

    Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial and its regulatory…

    CHARLOTTESVILLE, Va., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be filing an application for "Fast Track" with the U.S. Food and Drug Administration (FDA) for its lead drug candidate, AD04, which is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes.

    Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial and its regulatory advisors had previously concluded that AD04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.

    "Adial's correspondence and consultation with the FDA following its expedited review filing in September 2020, leads us to believe that AD04 qualifies for Fast Track consideration," said Adial's Head of Regulatory, Dr. Jack Reich. "I am confident Alcohol Use Disorder qualifies as a serious condition and that there is an unmet medical need, based on our communication with the FDA and as set forth in the FDA's Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics."

    "We are working with our regulatory counsel to prepare our Fast Track submission after consultation with the FDA," commented Adial's CEO, William Stilley. "Following our submission, the FDA is expected to review the request and make a decision within 60 days."

    The FDA's Fast Track is a process designed to facilitate development and expedite the regulatory review of drugs that treat serious conditions and address unmet medical needs with the purpose of getting important drugs to patients earlier. While the FDA judges the seriousness of a condition on a case-by-case basis, the FDA generally considers whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, left untreated, will progress to a more serious state. Depression is one such disease that is considered to be a serious condition for Fast Track purposes, and Adial believes that Alcohol Use Disorder will be treated similarly.

    When reviewing a Fast Track application where there are available therapies, the Fast Track drug must demonstrate advantages over the available therapy currently approved for the indication in order to be considered as meeting an unmet medical need. Examples of advantages considered by the FDA that Adial believes are applicable to AD04 include: (1) has an effect on a serious outcome of the condition in patients who are unable to tolerate or failed to respond to available therapy; (2) decreases a clinical significant toxicity of an available therapy that is common and causes discontinuation of a treatment; (3) provides safety and efficacy comparable to those of available therapy but has a benefit that is expected to lead to an improvement in serious outcomes; and (4) has the ability to address emerging or anticipated public health need.

    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, and the Company develops 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 AD04 qualifying for Fast Track consideration, the FDA treating AD04 similarly to depression for Fast Track designation purposes, Alcohol Use Disorder qualifying as a serious condition and being an unmet medical need and the timing of the FDA review and decision process for the Company's Fast Track Designation request 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, to the FDA determining that AD04 qualifies for Fast Track Designation, 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:



    Primary Logo

    View Full Article Hide Full Article
  3. CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2021 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer of Adial Pharmaceuticals has been invited to present a Company overview at the 23rd Annual ICR Conference on Thursday, January 14, 2021 at 3:15pm-3:55pm Eastern Time.

    A live webcast of the Company's presentation will be available on the Investors section of the Company's website (https://www.adialpharma.com/). A webcast replay will be accessible for 90 days following the live presentation.

    About Adial Pharmaceuticals, Inc.

    Adial Pharmaceuticals is a clinical-stage…

    CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2021 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that William Stilley, Chief Executive Officer of Adial Pharmaceuticals has been invited to present a Company overview at the 23rd Annual ICR Conference on Thursday, January 14, 2021 at 3:15pm-3:55pm Eastern Time.

    A live webcast of the Company's presentation will be available on the Investors section of the Company's website (https://www.adialpharma.com/). A webcast replay will be accessible for 90 days following the live presentation.

    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.

    Contact:

    Crescendo Communications, LLC
    David Waldman / Natalya Rudman
    Tel: 212-671-1021
    Email:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/623791/Adial-Pharmaceuticals-to-Present-at-23rd-Annual-ICR-Conference

    View Full Article Hide Full Article
  4. CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced receipt of a Notice of Allowance for its third U.S. patent relating to the use of AD04 for the treatment of opioid use disorder (OUD). The patent covers the use of the Company's lead product, AD04, as a treatment of Opioid Use Disorder in patients with a specific genetic biomarker in the serotonin transporter gene.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "We are pleased to announce our third patent for AD04 for the treatment of Opioid Use Disorder, which is both a large and an underserved…

    CHARLOTTESVILLE, VA / ACCESSWIRE / January 11, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced receipt of a Notice of Allowance for its third U.S. patent relating to the use of AD04 for the treatment of opioid use disorder (OUD). The patent covers the use of the Company's lead product, AD04, as a treatment of Opioid Use Disorder in patients with a specific genetic biomarker in the serotonin transporter gene.

    William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, "We are pleased to announce our third patent for AD04 for the treatment of Opioid Use Disorder, which is both a large and an underserved market. As we continue to study AD04 in our landmark ONWARD™ Phase 3 pivotal clinical trial for the treatment of Alcohol Use Disorder, our goal is to confirm the findings of the Phase 2b trial, which demonstrated the efficacy of AD04 as a treatment for Alcohol Use Disorder. We believe the primary mechanism of action through which AD04 produces its pharmacological effect is through inhibiting activation of the serotonin-3 receptor in the brain, thereby blocking effects on the dopamine system. We see significant potential in AD04 for the treatment of Opioid Use Disorder since the physiology and neuro-transmitters involved in opioid addiction are similar to alcohol and could be expected to be modulated by a serotonin-3 receptor antagonist."

    According to the U.S. Centers for Disease Control and Prevention, an estimated 2 million people in the U.S. had an opioid use disorder in 2018 and nearly 70% of drug overdose deaths were attributed to opioids. "Sadly, we believe these numbers have grown significantly due to the ongoing pandemic, and we are hopeful that AD04 may provide a desperately needed treatment option for those suffering from opioid addiction," added Mr. Stilley.

    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 confirming the findings in the Phase 2b trial that the primary mechanism of action through which AD04 produces its pharmacological effect is through inhibiting activation of the serotonin-3 receptor in the brain and blocking effects on the dopamine system, the potential in AD04 for the treatment of Opioid Use Disorder and the potential of AD04 to treat other addictive disorders such as alcohol 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 confirm the findings in the Phase 2b trial that the primary mechanism of action through which AD04 produces its pharmacological effect is through inhibiting activation of the serotonin-3 receptor in the brain, thereby blocking effects on the dopamine system, the ability of AD04 to be a treatment option for those suffering from opioid addiction and other addictive disorders, 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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/623785/Adial-Pharmaceuticals-Receives-Notice-of-Allowance-for-Third-US-Patent-Covering-AD04-for-the-Treatment-for-Opioid-Use-Disorder

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  5. 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…

    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:

    SOURCE: Adial Pharmaceutical, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/621391/Adial-Pharmaceuticals-Reaches-35-Enrollment-in-ONWARDTM-Pivotal-Phase-3-Trial-of-AD04-for-the-Treatment-of-Alcohol-Use-Disorder

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