Adial Pharmaceuticals, Inc. (ADIL) stock prices were up by a significant 16.21% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$2.94 at the end of the trading day.
Inclusion in Russell Microcap Index
June 28th, 2021 saw the company announce its inclusion in the Russell Microcap Index, effective as of the market opening on the same day. Inclusion in the index is indicative of the company’s progress in advancing its lead investigational new drug product, AD04, through ADIL’s ONWARD Phase 3 trial for the treatment of alcohol use disorder. Further contributing to the addition in the index was the company’s recent acquisition of Purnovate, along with its adenosine drug development platform.
Fast Track Designation Denied
The company reported near the end of June 2021 that its request for Fast Track Designation for the use of AD04 in the treatment of Alcohol Use Disorder had been denied by the U.S. Food and Drug Administration. The FDA cited the company’s failure to adequately demonstrate the potential of its treatment, with the agency requesting additional comparative information in contrast to other alternative therapies.
Gaining Approval
As per the denial, ADIL will assess the FDA’s requirements to facilitate approval of a Fast Track Designation, which is designed to facilitate development and hasten the process of regulatory review of drugs. AD04 is currently undergoing a Phase 3 ONWARD trial, with the primary endpoint of efficacy being marked by the change from baseline in the monthly number of heavy drinking days during the last eight weeks of the 24-week treatment period.
ONWARD Trial
The ONWARD trial is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study that lasts a period of 24 weeks. It is designed to evaluate the efficacy, safety, and tolerability of AD04 in the treatment of patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes. The ONWARD trial ensured only genetically positive patients were enrolled by genetically screening patients prior to enrollment. The primary endpoint is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period.
Future Outlook for ADIL
Despite the speed bump presented by the FDA’s denial of Fast Track Designation for AD04, ADIL is poised to address and resolve the issue and continue the development of its flagship treatment. Investors are hopeful for a timely resolution and the resumption and acceleration of the commercialization of AD04.
