Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced the recent execution of agreements for the production of AD04 (0.33 mg ondansetron tablets), supporting both the completion of upcoming clinical trials and the planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the treatment of Alcohol Use Disorder (AUD) in the US. AD04 is the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients.
The strategic collaboration with Thermo Fisher Scientific as the Contract Development and Manufacturing Organization (CDMO) for AD04 Drug Product, and Cambrex, a drug substance CDMO and supplier of Ondansetron API, has begun and is already seeing results in completion of the demonstration batches required prior to the conduct of the registration and clinical batches. The importance of choosing CDMOs with both drug substance development and manufacturing capabilities with successful track records was a key element to the signing of the agreements. The agreements include all phases of manufacturing for both the clinical supplies needed to conduct the upcoming clinical studies for AD04, as well as the Chemistry, Manufacturing, and Controls (CMC) module documentation required for the submission of the NDA to the FDA.
Cary Claiborne, President and Chief Executive Officer of Adial commented, “As our readiness in planning the future Phase 3 registrational study program for AD04 continues, 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. The combination of Thermo Fisher and Cambrex makes for a strong collaboration for Adial in our quest to develop AD04 for the treatment of AUD. Choosing a contract manufacturer which can meet our timelines for starting the clinical program is paramount. It was important for the CDMOs to be on sound financial footing, but also to have drug substance manufacturing as well as drug product manufacturing in the US to meet the eventual commercial demands of AD04 given recent tariff implications for our industry. It is equally important to have confidence in the drug substance manufacturer and their ability to consistently supply the needs of Adial. We believe these relationships will be invaluable as we move forward with the initiation of our Phase 3 trials.”
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