Draft:Adial Pharmaceuticals

Adial Pharmaceuticals (Adial Pharmaceuticals, Inc.) is a clinical-stage biopharmaceutical company, focused on the development of therapeutics for the treatment or prevention of addiction and related disorders.

History
Adial Pharmaceuticals was founded in 2010 and was listed on the NASDAQ exchange in 2018 under the symbol ADIL.

Adial licensed the Intellectual Property for its lead candidate AD04, ondansetron .33mg in combination with genetic biomarkers, from the University of Virginia in 2011 with the intention to develop a treatment or prevention for addiction and related disorders.

The licensed Intellectual Property covering AD04 includes 90 issued patents in 43 jurisdictions, plus 7 pending applications. Adial went public with IPO on June 30, 2018. In in August of 2022, Cary Claiborne was appointed as Adial's Chief Executive Officer and President after serving as its Chief Operating Officer since December of 2021.

In January of 2024, Tony Goodman was appointed as Adial's Chief Operating Officer to oversee Adial's strategic growth initiatives, including clinical development and commercial planning for AD04.

Major announcements
In May 2019, Adial announced a collaboration agreement with Eurofins Scientific, a global scientific leader in bioanalytic test, to provide the genetic testing during Adial Pharmaceutical's planned Phase III clinical trials.

In January 2021 Adial acquired Purnovate, LLC, a pharmaceutical development company focused on adenosine analogs.

In July 2022, Adial announced topline results for its Onward™ Phase 3 Trial for AD04 in Patients with Alcohol Use Disorder.

In July 2023, after meeting with the FDA and country-level regulatory agencies in Europe, Adial announced a revised company strategy and clinical development focus on two specific single nucleotide polymorphisms of the serotonin genetic biomarker, AG(+) and GG(+) which are present in 20% of the population. Adial intends to conduct two additional Phase 3 trials with AD04 that will include both the US and EU endpoints and will be designed to satisfy both submission requirements.

As of September 2023, Adial had sold Purnovate and held a minority interest in Adovate, LLC (formerly Purnovate, LLC) which is focused on inventing and developing best-in-class adenosine receptor agonists and antagonists.

In October 2023, Adial closed private placement offering for the purchase and sale of 1,418,440 shares of its common stock, and series A and series B warrants, raising gross proceeds of approximately $4 million.

Indications
Since its formation in 2011, Adial Pharmaceuticals has developed therapeutics for patients who suffer from addiction and related disorders.

Alcohol Use Disorder (AUD) is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It encompasses the conditions that are also referred to as alcohol abuse, alcohol dependence, alcohol addiction, alcoholism.

Adial is currently evaluating its lead candidate, AD04, as a therapeutic agent for the genetically targeted, non-abstinence-based treatment of AUD. AD04, acts as a serotonin-3 receptor antagonist that could affect neurotransmitters like dopamine and modulate the behavioral effects of alcohol.

The Phase IIb clinical trial involved a genetically targeted patient group suffering from AUD. The data from the clinical trial demonstrated a 50% reduction in the frequency of drinking in the AD04 versus placebo group, and an almost 60% reduction in how much the participants drank overall.

Topline data from the ONWARD™ clinical trial was announced in July of 2022. The ONWARD™ trial was a Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with AUD and selected polymorphisms in the serotonin transporter and receptor genes. AD04 achieved statistically significant mean reduction in heavy drinking days (average <10 drinks per drinking day) among pre-specified group of heavy drinkers, compared to placebo, with an approximately 79% reduction from baseline drinking. It also demonstrated statistically significant difference in AUD severity, as compared to placebo, with an 84% decrease in the number of heavy drinking patients meeting the criteria for AUD diagnosis. However, the trial did not meet its primary endpoint for the average change in heavy drinking when calculated as a percentage of heavy drinking days (PHDD) in study months 5 and 6 compared with placebo for the total enrolled population. AD04 also showed safety and tolerability that compared favorably to placebo.