Adial’s AD04 for the treatment of alcohol use disorder received a Notice of Allowance from the US Patent and Trademark Office.
Precision medicine took another step forward as Adial Pharmaceuticals announced their intent to enter the genetic testing market. The news comes after the company received a Notice of Allowance from the US Patent and Trademark Office related to use of their genetic diagnostic panel in combination with their lead product, AD04, designed to treat addictive disorders.
“This new patent related to the use of our genetic diagnostic panel in combination with AD04 for the treatment of AUD and OUD is a major milestone as we believe genetic evaluation of patients can be used to identify individuals that may benefit from AD04. We have been utilizing the genetic panel covered by this patent in our ongoing ONWARD™ Phase 3 trial, and, given this patent allowance, we anticipate that genetic diagnostics are expected to be an important segment of our commercial strategy going forward,” Adial’s CEO, William Stilley, said in a statement to the press. “Our view that AUD has a solid nexus in genetics is fundamental to the premise of the successful Phase 2B trial of AD04 conducted at the University of Virginia and our ONWARD™ Phase 3 trial of AD04 currently underway in Europe. And, it is consistent with Adial’s premise that the presence of certain genetics is expected to substantially influence whether an individual suffering from AUD or OUD would likely respond to treatment with AD04.”1
AD04 is a genetically targeted therapeutic agent for the treatment of AUD. The drug is designed to reduce cravings thereby reducing alcohol intake. patients curb their drinking. The oral medication will not require abstinence before or during treatment. To date, it has shown positive safety and tolerability profiles.2
Once issued, the patent is anticipated to provide market exclusivity for the AD04 genetic diagnostic test. With this in mind, Adial plans to enter the genetic testing market as a stand-alone commercial business line and market the genetic diagnostic panel as a Companion Diagnostic Test to AD04. Approximately one-third (33%) of AUD patients are expected to respond to treatment with AD04.
In addition to the benefits for patients, the resulting efficacy may also realize cost savings to the health care industry. “Market research conducted by Adial indicates a willingness among payors to reimburse a genetic companion diagnostic test, and this may allow Adial to provide patients personalized, precision medicine and also potentially provide dramatic cost savings to payors,” Stilley said further.1
1. Adial Pharmaceuticals. Adial Pharmaceuticals plans to enter genetic testing market following allowance of US Patent for genetic diagnostic test. News release. June 22, 2021. Accessed June 22, 2021. https://ir.adialpharma.com/press-releases/detail/122/adial-pharmaceuticals-plans-to-enter-genetic-testing-market
2. Adial Pharmaceuticals. Technology. Accessed June 22, 2021. https://www.adialpharma.com/technology/