Adial Pharmaceuticals, Inc. (NASDAQ:ADIL), a micro-cap pharmaceutical company with a market capitalization of $3.62 million, has secured manufacturing agreements with Thermo Fisher Scientific and Cambrex to produce its investigational alcohol use disorder treatment AD04, the company announced Wednesday.
The agreements cover production of AD04 (0.33 mg ondansetron tablets) for upcoming clinical trials and the planned New Drug Application submission to the U.S. Food and Drug Administration. Demonstration batches required before registration and clinical batches have already been completed. With its current ratio of 1.99,
Thermo Fisher will serve as the Contract Development and Manufacturing Organization for the drug product, while Cambrex will supply the ondansetron active pharmaceutical ingredient under an FDA-approved Drug Master File.
"These agreements with Thermo Fisher and Cambrex are another key component in our planning for the upcoming conduct of the AD04 clinical trial program and to meet our requirements for the FDA," said Cary Claiborne, President and CEO of Adial Pharmaceuticals.
The collaboration includes manufacturing for clinical supplies and preparation of Chemistry, Manufacturing, and Controls documentation required for FDA submission.
AD04 is Adial’s genetically targeted, serotonin-3 receptor antagonist being developed for Alcohol Use Disorder in heavy drinking patients. The company recently completed its ONWARD pivotal Phase 3 clinical trial, which showed promising results in reducing drinking with no overt safety concerns.
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