Adial Pharmaceuticals Inc. (ADIL) announced a collaboration with Boudicca Dx, LLC, a global precision medicine testing accelerator, on Tuesday. This partnership focuses on advancing the technical and regulatory strategy for Adial’s companion diagnostic genetic test. The test is designed to identify patients who may benefit from AD04, a potential treatment for Alcohol Use Disorder (AUD).
The collaboration will ensure the companion diagnostic test meets FDA guidelines for validation, both technically and clinically. This is a crucial step in Adial’s regulatory strategy for AD04, a genetically-targeted, serotonin-3 receptor antagonist therapeutic agent.
The companion diagnostic test is intended to play a key role in the upcoming Phase 3 study of AD04. It will help identify potential patients and recruit them for the trial. Cary Claiborne, President and Chief Executive Officer of Adial, emphasized the importance of this partnership, stating, “As we continue to prepare for the Phase 3 study for AD04, this agreement with Boudicca Dx is another key component toward achieving clinical success and is expected to support our next FDA interaction.”
Kelly Gordon, from Boudicca Dx, highlighted the significant unmet need for targeted therapies for AUD. She commented, “The Boudicca Dx team is excited to support the development of a first-in-class companion diagnostic test for AD04, a precision medicine designed to treat patients with Alcohol Use Disorder. This disease affects more than 30 million people in the US alone and causes 3 million deaths worldwide each year. There is a high unmet need for a targeted therapy and its companion diagnostic test.”
The collaboration with Boudicca Dx represents a significant step forward for Adial Pharmaceuticals as they prepare for the Phase 3 study of AD04. The companion diagnostic test has the potential to greatly enhance the effectiveness of AD04 by ensuring that it is prescribed to patients who are most likely to benefit from the treatment.
ADIL stock closed at $0.97 on Monday.
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