EXCLUSIVE: Adial Pharmaceuticals Advances Regulatory Strategy For Companion Diagnostic Genetic Test For Its Lead Program For Alcohol Use Disorder

On Tuesday, Adial Pharmaceuticals Inc. ADIL announced a collaboration with Boudicca Dx, LLC, a global precision medicine testing accelerator.

Under the agreement, Boudicca will support Adial in advancing its technical and regulatory strategy for the company’s companion diagnostic genetic test to ensure it is validated technically and clinically per FDA guidelines as part of Adial’s regulatory strategy for its lead investigational asset, AD04.

Also Read: EXCLUSIVE: Adial Pharmaceuticals’ Last Patient Dosed in Pharmacokinetics Study of AD04 For Alcohol Use Disorder, Data Expected In Q4.

AD04 is a genetically-targeted, serotonin-3 receptor antagonist therapeutic agent for Alcohol Use Disorder (AUD).

Adial’s companion diagnostic is intended to assist AD04 in identifying potential patients and recruiting for the planned Phase 3 program.

Cary Claiborne, President and Chief Executive Officer of Adial, commented, “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 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.”

Price Action: ADIL stock closed at $0.97 on Monday.

Read Next:

• EXCLUSIVE: Adial Pharmaceuticals Moves Forward To Second Cohort In Pharmacokinetics Study of AD04 For Alcohol Use Disorder.