Benzinga | Aug 10, 2021 09:30AM EDT

Adial Pharmaceuticals Awarded U.S. And International Patents For Treatment Of Alcohol And Opioid Use Disorders Using AD04

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided an update on recently issued patents for the use of Adial's lead asset, AD04, for the treatment of both Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD). AD04 is currently being evaluated in the Company's ONWARD trial, a Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with AUD, which is being conducted in seven countries.



Recently issued patents:

* U.S. Patent Number 16,807,379 covering the use of AD04 as a treatment for OUD in patients with a specific genetic biomarker in the serotonin transporter gene.

* Canadian Patent Number 2716498 covering the use of AD04 for both OUD and AUD in patients with specific genetic biomarkers in the serotonin transporter gene.

* Israeli Patent Number 262874 covering the use of AD04 as a treatment for OUD in patients with specific genetic biomarkers in the serotonin transporter gene.

* Brazilian Patent Number PI09084258 covering the use of AD04 as a treatment for OUD in patients with specific genetic biomarkers in the serotonin transporter gene.

The Company believes AD04 may hold significant potential for the treatment of OUD since the physiology and neurotransmitters involved in opioid addiction are similar to alcohol and could be expected to be modulated by a serotonin-3 receptor antagonist.

According to the U.S. Centers for Disease Control and Prevention, an estimated 2 million people in the U.S. had an opioid use disorder in 2018 and nearly 70% of drug overdose deaths were attributed to opioids

Commenting on the patents, William Stilley, Adial's Chief Executive Officer, stated, "We are encouraged by our recent patent activity, not only for obtaining patents for AD04 to treat AUD and OUD patients, but also for having recently obtained a Notice of Allowance on a patent for the use of our genetic diagnostic panel in combination with AD04 for both AUD and OUD, which represents another potentially significant business opportunity for the Company. As we have done with the rest of our patent estate, we continue our policy of pursuing patents internationally in any jurisdictions where we believe a robust and potentially profitable market exists, as demonstrated by not just the U.S. patent issuance, but recent issuances in Brazil, Canada and Israel. The use of AD04 for AUD is already covered by patents issued in over 45 jurisdictions."