Adial pharmaceuticals receive a positive response from the FDA meeting on the in vitro binding strategy for AD04

The FDA feedback confirms the in vitro bond strategy proposed by Adial to the phase 3 formulation to meet the connection requirement for 505 (B) (2) The regulatory registration path for approval

Adial goes on with the manufacture of clinical supplies for the clinical program of the 3rd phase in 2025

Glen Allen, VA., February 25, 2025 (Globe Newswire) – Adial Pharmaceuticals, Inc. (Nasdaq: adil) (“Adial” or “Company”), a biopharmaceutical company in a clinical stage focused on the development of therapies for the treatment and prevention of addiction and related disorders, today announced a positive response from the US Administration for Food and Drugs (FDA) in what It concerns the proposed proposal the in vitro connection strategy for AD04.

The FDA feedback follows the submission Adial on November 19, 2024, in which the company requested the Agency’s guidance on the alignment of its AD04 formulation strategy and the connection approach. This stage is crucial, because it ensures compliance with the regulatory approval path 505 (B) (2) (2) Regulatory approval after the completion of the study AD04-103, a pivot clinical study to support the development of the drug. The company also proposed to ensure the confirmation from the FDA that the proposed data package would meet the necessary connection requirements and allow the AD04 progression in the clinical trials in phase 3.

In response, the FDA agreed with the connection strategy with 505 (B) (2) (2) by Adial, which involves the use of results from AD04-103-A relative dietary bioavailability, with in vitro dissolution , which demonstrates the equivalence between the reference product and the planned commercial formulation of AD04. While the final determination will depend on a comprehensive review of the complete drug (NDA) request, the FDA agreement reports a significant regulatory stage for addition.

With this regulatory confirmation in force, the addition is proceeding to the manufacture of clinical supply materials in the preparation of its 325 phase clinical program. on the market as on the market, because a potential advanced therapy for addiction.

“This stage is an essential step forward in our efforts to advance ad04 in phase 3 of clinical development and, finally, to approve the regulation,” said Cary Claibborne, CEO of Pharmaceuticals Adial. Closer to achieving our goal to provide a new treatment option for patients who are struggling with addiction. “

About adial pharmaceuticals, inc.

Farmaceutical Adial is a biopharmaceutical company in a clinical stage focused on the development of therapies for the treatment and prevention of addiction and related disorders. The investigation product of the new company investigation medicine, AD04, is an antagonist of the Serotonin-3 receiver, therapeutic agent for the treatment of alcohol consumption disorder (AUD) in patients with heavy drinks and has recently been investigated in the pivotal phase 3 Pivotal 3 Clinical Clinics of Onward Clinical Clinical Clinical Clinical Clinical The Clinical Clinical Clinical of Onward Test for the potential treatment of audits with certain target genotypes using the genetic diagnostic test of the company’s accompanying company. Next, it has shown promising results in reducing heavy drinks in patients with heavy drinks and without excessive safety or tolerability. It is also believed that the AD04 has the potential to treat other dependent disorders, such as opioid use disorder, gambling and obesity. Further information is available at www.adial.com.

If you are interested in exploring the partnership opportunities with Adial, we invite you to address ((e -mail protected)) to discuss how our common efforts can bring positive changes to millions of patients who are struggling with addiction.

Prospective statements

This communication contains certain “prospective statements” within the meaning of the federal laws of the US furniture. Such statements are based on various facts and derived using numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that can cause real results, performance or achievements that are significantly different from future results, performance or achievements expressed or involved. through such prospective statements. The statements preceded by, followed by, or otherwise include the words “believe”, “expect”, “anticipate”, “intend”, “projects”, “estimations”, “plans” and similar or conditioned expressions, such as be “Will,” “should”, “would be”, “May” and “could” generally with a more prospect in nature and not in historical facts, although not all statements Prospective include the above. Prospective statements include statements regarding the connection strategy of 505 (B) (2) (2) of the company, proceeding with the manufacture of clinical supply materials in the preparation of the clinical program of the company in 2025, the execution of the company’s development plan and working closely with the regulatory authorities to bring Ad04 to the market as a potential advanced therapy for addiction, advancement AD04 in the clinical development of phase 3 and, finally, for approval regulation, achieving the goal of providing a new treatment option for patients who are struggling with addiction and potential ad04 to treat other dependent disorders, such as disorder Use of opioids, gambling and obesity. Any prospective statements included in here reflect our current opinions and involve certain risks and uncertainties, including, among other things, our ability to follow our regulatory strategy, our ability to advance the ongoing partnership discussions, our ability to obtain Regulatory approvals for marketing candidates for products or complying with the ongoing regulatory requirements, our ability to develop opportunities of Strategic partnership and to maintain collaborations, our ability to obtain or maintain the capital or subsidies needed to finance our research and development activities, our ability to complete clinical studies on time and to achieve the desired results and benefits, as It was expected, the regulatory limitations on our ability to promote or market our products for specific indications, acceptance of our candidates of market products and successful development, marketing or selling our products, our ability to maintain our license agreements, maintenance and continuous growth of our patent property and our ability to keep our employees or keep our NASDAQ list. . These risks should not be interpreted as exhaustive and should be read together with the other caution statement included in our annual report on form 10-K for the year ended on December 31, 2023, subsequent quarterly reports on form 10-Q and current Form 8 reports -K submitted to Securities and Exchange Commission. Any prospective statement speaks only from the date on which it was made originally. We assume no obligation to update or publicly review any prospective statement, either as a result of new information, future events, circumstances exchanged or otherwise, unless it is requested by law.

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