Adial Pharmaceuticals Inc. (NASDAQ:ADIL) has announced that its breakthrough ONWARD pivotal third phase clinical study in Poland has received approval for the evaluation of AD04.
Adial receives approval for ONWARD study in Poland
The study will evaluate AD04 as a potential therapeutic agent for Alcohol Use Disorder treatment in people with specific target genotypes associated with receptor and serotonin transporter genes. The approval includes the Registration of Medicinal Products Biocidal Products as well as Medical Devices. It also includes other necessary regional Polish Ethics Committees that will oversee the study.
Schuyler Vinzant, the company’s VP of Development, indicated that Poland was among the largest countries in Europe, and as a result, it will be vital in the rapid enrolment of patients in the ONWARD study. Vinzant added that although regulatory review in the country was on hold because of the COVID-19 situation, once the reviews commenced, the process of approval of the study has been unexpectedly fast.
Adial Acquired Rapid Result test kits to incorporate in ONWARD study
Recently the company announced that it received a first firm order for purchasing up to 1,000 Rapid COVID-19 Result test kits. The customer is planning to use the test kits in gaining insight about exposure to COVID-19 in Phoenix, Arizona. This will help in advancing efforts to protect the safety and health of frontline health workers. This came following a distribution agreement signed early in the month with BioLab Sciences Inc.
According to the distribution agreement, Adial acquired the Rapid Result test kits from BioLab to use in its breakthrough ONWARD third phase trial. BioLab granted the company exclusive rights of selling the Rapid COVID-19 Result antibody testing kits to various designated channel customers and partners. The Rapid Result test kit is an FDA-registered point-of-care test kit for the detection of IgM and IgG antibodies specific to coronavirus in human serum, blood, and plasma. During testing, a specimen will react with the 2019-nCOVantigen particles in the test kit after blood droplets are put in an antigen-coated cassette membrane.