Adial Partners with Boudicca Dx to Advance Regulatory Strategy for AD04 Genetic Test

Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, recently announced its collaboration with Boudicca Dx, LLC. This partnership aims to enhance Adial's technical and regulatory strategy for its companion diagnostic genetic test, ensuring FDA compliance. This diagnostic test is an integral part of Adial's approach for their lead investigational therapy, AD04, which targets Alcohol Use Disorder (AUD).

Alcohol Use Disorder is a significant public health issue, affecting over 30 million individuals in the United States and resulting in three million deaths globally each year. AD04 is a genetically targeted serotonin-3 receptor antagonist designed to treat AUD in patients prone to heavy drinking. The companion diagnostic genetic test is instrumental in identifying patients who may benefit from AD04, particularly in Adial's upcoming Phase 3 clinical program.

Commenting on the partnership, Cary Claiborne, President and CEO of Adial, emphasized the importance of this collaboration with Boudicca Dx. He noted that as Adial prepares for its Phase 3 study for AD04, working with Boudicca Dx represents a critical step toward clinical success and regulatory approval. Kelly Gordon, CEO and founder of Boudicca Dx, and her team are considered ideal partners for developing a comprehensive clinical, regulatory, and commercial strategy for AD04's companion diagnostic.

Kelly Gordon expressed her enthusiasm for supporting the development of the companion diagnostic test for AD04. She underscored the high unmet need for targeted therapies and diagnostic tools to treat AUD, given the disease's significant impact on public health.

Adial Pharmaceuticals is dedicated to developing treatments for addictions and related disorders. Their lead investigational product, AD04, showed promising results in the ONWARD Phase 3 clinical trial, reducing heavy drinking among target genotypes without notable safety concerns. Besides AUD, AD04 has potential applications in treating other addictive disorders, such as Opioid Use Disorder, gambling, and obesity.

The collaboration with Boudicca Dx signifies a strategic move by Adial to ensure their companion diagnostic meets FDA guidelines and supports the clinical and commercial success of AD04. This partnership is expected to facilitate the identification and recruitment of suitable patients for Adial's Phase 3 trials, thereby advancing their goal of introducing a precision medicine approach to AUD treatment.