September 23, 2020 -- Vivet Therapeutics and Pfizer have entered into a manufacturing agreement where Pfizer will provide clinical supply for a phase I/II clinical trial evaluating Vivet's proprietary investigational adeno-associated virus-based gene therapy, VTX-801, for the potential treatment of Wilson's disease.
In 2019, Pfizer acquired a minority equity interest in Vivet and secured an exclusive option to acquire all outstanding shares.
In March 2019, the companies had announced a collaboration on the development of VTX-801, which was given orphan drug designation. Wilson's disease is caused by mutations in the gene encoding the ATP7B protein, which reduces the ability of the liver and other tissues to regulate copper levels causing severe hepatic damages, neurologic symptoms, and potentially death.
An investigational new drug application for the therapy is planned to be filed with the U.S. Food and Drug Administration in 2020.
The phase I/II clinical supply will be manufactured in Pfizer's facility in Chapel Hill, NC. Pfizer has made recent investments to strengthen the company's gene therapy manufacturing facilities in North Carolina to produce clinical and commercial scale quantitates of gene therapies.
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