Adial Pharmaceuticals Submits Patent Update for AD04, Targets Alcohol Use Disorder

Adial Pharmaceuticals has submitted an update to its provisional patent application for AD04, a drug designed to target Alcohol Use Disorder. The patent pertains to a genetically tailored serotonin-3 receptor antagonist and is expected to safeguard Adial's core innovation and extend exclusivity up to 2045. Two analysts have set a one-year average target price of $4.00, implying an upside of 1,157.86% from the current price of $0.32. The average brokerage recommendation is currently 2.0, indicating "Outperform" status.

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL), a micro-cap biopharmaceutical company, has recently filed an update to its provisional patent application for AD04, an investigational treatment for Alcohol Use Disorder (AUD). The update, which follows an initial filing in July 2024, aims to extend patent protection for the company’s core assets until at least 2045 [1].

AD04 is a genetically targeted, serotonin-3 receptor antagonist therapeutic agent designed to treat AUD in heavy drinking patients, defined as those consuming fewer than 10 drinks per drinking day. The patent application was the result of an extensive examination of data and information following the hiring of new patent counsel, enhancing Adial’s intellectual property portfolio [1].

The company is preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration scheduled for July 29. The company previously conducted a Phase 3 clinical trial called ONWARD, which showed promising results in reducing drinking in heavy drinking patients with no overt safety or tolerability concerns [1].

Analysts have set a one-year average target price of $4.00 for Adial Pharmaceuticals, implying an upside of 1,157.86% from the current price of $0.32. The average brokerage recommendation is currently 2.0, indicating an "Outperform" status [2].

Adial Pharmaceuticals focuses on developing therapies for addiction and related disorders, using a companion diagnostic genetic test to identify patients with specific target genotypes who may respond to its treatment [1].

The company has also made significant strides in its development efforts for AD04, securing manufacturing agreements with Thermo Fisher Scientific and Cambrex to produce AD04 tablets for upcoming clinical trials and a planned New Drug Application submission to the FDA [1].

Adial has priced a public offering of 11,100,000 shares of common stock and accompanying warrants, expected to generate approximately $3.6 million in gross proceeds, with A.G.P./Alliance Global Partners serving as the sole placement agent [1].

The company has advanced the design of its Phase 3 trial for AD04, collaborating with Cytel Inc. to refine the trial strategy and target specific genetic subpopulations. This refined approach aims to optimize trial design through advanced statistical analytics and simulation modeling [1].

Adial Pharmaceuticals has also announced changes to its 2025 Annual Meeting of Stockholders, now scheduled for August 1, 2025, with new deadlines for shareholder proposals and proxy solicitations. These developments reflect Adial’s ongoing efforts to advance its clinical programs and engage with its shareholders effectively [1].

References:
[1] https://www.investing.com/news/company-news/adial-pharmaceuticals-files-patent-update-for-alcohol-disorder-treatment-93CH-4128199
[2] https://step2.medbullets.com/psychiatry/120661/substance-intoxication-and-withdrawal