Adial Pharmaceuticals Announces International Patent Application for AD04
Adial Pharmaceuticals announced the publication of the international patent application for AD04, filed in July 2024. AD04 is the Company's lead investigational genetically targeted serotonin-3 receptor antagonist therapeutic agent for the treatment of Alcohol Use Disorder in heavy drinking patients. The patent, once granted, is expected to protect Adial's core assets through at least 2045. Cary Claiborne, President and Chief Executive Officer of Adial, commented, "As we continue to advance the AD04 program with planning for the next phase of our clinical program, the new patent application and its expected approval will extend protection of the core assets of Adial out to at least 2045. This application is the result of an extensive examination of data and information which occurred after Adial hired new patent counsel to bolster and leverage Adial's intellectual property portfolio."
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- Legislative Support for New Therapies: The 2026 Appropriations Bill passed by Congress mandates collaboration between the FDA and NIDA to establish alternative clinical trial endpoints, emphasizing non-abstinence outcomes like reduced cravings, which is expected to enhance the regulatory pathway for Adial's AD04 therapy.
- Precision Medicine Strategy: Adial's investigational therapy AD04 is designed to treat Alcohol Use Disorder (AUD) using a precision medicine approach, aligning with the new legislation's focus on non-abstinence recovery goals, potentially accelerating clinical trial timelines and broadening clinical relevance.
- Public Health Challenge: AUD remains a significant public health issue affecting millions, and the passage of the new bill may provide Adial with clearer regulatory frameworks to address this substantial unmet treatment need.
- Impact of Policy Change: Adial's CEO Cary Claiborne noted that this legislation reflects a meaningful evolution in the evaluation and treatment of substance use disorders, which may foster innovation and improve clinical outcomes for patients.
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- Positive Stock Reaction: In pre-market trading, Super Micro's shares jumped 10.5% to $32.79, indicating a favorable market response to its strong earnings and optimistic outlook.
- Reverse Stock Split: Adial Pharmaceuticals announced a 1-for-25 reverse stock split effective Thursday, reducing outstanding shares from 27.8 million to approximately 1.1 million, aimed at regaining compliance with Nasdaq's minimum bid price requirement, although this led to a more than 20% drop in after-hours trading.
- AD04 Development Progress: The reverse split coincides with Adial's advancement of AD04, a genetically targeted treatment for Alcohol Use Disorder, with Phase 3 trial design completed, focusing on heavy drinkers and specific genotypes, indicating positive clinical progress for the company.
- FDA Regulatory Discussions: Adial has completed End-of-Phase-2 discussions with the FDA, receiving input on the Phase 3 adaptive trial design and broader clinical program, covering key elements such as patient population and endpoints, ensuring focus on biomarker-positive and negative groups.
- Strengthened Intellectual Property: The company has enhanced intellectual property protection for AD04, with an international patent application published, expected to safeguard core assets until at least 2045, reflecting a long-term strategic vision for market positioning.











