Adial Pharmaceuticals Plans to Enter Genetic Testing Market Following Allowance of U.S. Patent for Genetic Diagnostic Test
Adial Pharmaceuticals has announced plans to enter the genetic testing market following a Notice of Allowance from the U.S. Patent and Trademark Office. This patent covers the use of a genetic diagnostic panel in combination with its product AD04 for treating Alcohol Use Disorder (AUD) and potentially Opioid Use Disorder (OUD). The company estimates a multi-billion dollar market opportunity, anticipating that genetic evaluations can help identify patients likely to benefit from AD04. If approved, the patent will provide market exclusivity, enhancing Adial's commercial strategy.
- Notice of Allowance for genetic diagnostic panel patent signifies potential market exclusivity for AD04.
- Potentially multi-billion dollar market opportunity for genetic companion diagnostic test targeting AUD.
- Market research indicates payors are open to reimbursing genetic companion diagnostic tests.
- The ONWARD Phase 3 trial of AD04 shows promise in identifying genetically suitable patients for treatment.
- None.
The Company believes the genetic companion diagnostic test for AD04 for Alcohol Use Disorder represents a multi-billion dollar potential market opportunity
CHARLOTTESVILLE, Va., June 22, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced plans to enter the genetic testing market after it received a Notice of Allowance from the U.S. Patent and Trademark Office related to use of the Company’s genetic diagnostic panel in combination with the Company’s lead product, AD04, for the treatment of Alcohol Use Disorder (AUD). The patent covered by the Notice of Allowance also pertains to the Company’s use of its genetic diagnostic panel in combination with AD04 for the treatment of Opioid Use Disorder (OUD).
“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,” said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. “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.”
The recently allowed patent, once issued, is expected to provide market exclusivity for the AD04 genetic diagnostic test, creating a possibly significant profit center for the Company. Therefore, assuming approval by either the U.S. or European regulatory authorities, Adial plans to enter the genetic testing market as a stand-alone commercial business line and develop and market the genetic diagnostic panel as a Companion Diagnostic Test to AD04 for identification of the approximately one-third (
Commenting on the potential market for Adial’s genetic companion diagnostic test for AD04 for the treatment of AUD, Mr. Stilley stated, “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. Our models estimate the payback period for payors would be under 12 months at expected pricing, and, with 35 million people in the United States estimated to have AUD, we believe the total potential market for our companion diagnostic genetic test could be a multi-billion dollar opportunity in the United States alone.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity, and the Company develops adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adialpharma.com.
About the Landmark ONWARD™ Pivotal Phase 3 Clinical Trial
The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.
Forward Looking Statements
This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding plans to enter the genetic diagnostic testing market as a stand-alone commercial business line, using genetic evaluation to identify the approximately one-third (
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FAQ
What is Adial Pharmaceuticals' recent patent announcement regarding AD04?
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