PARIS, April 8, 2024 /PRNewswire/ -- Vivet Therapeutics ('Vivet'), a clinical stage biotech company developing novel and long-lasting gene therapies for rare inherited liver metabolic disorders, today announces that it has dosed its first patient with its lead program VTX-801 in Cohort 2 of its ongoing GATEWAY Clinical Trial for the treatment of Wilson Disease (WD). Initiation of Cohort 2 followed the successful completion of Cohort 1 and approval from an independent Data Monitoring Committee (DMC) to proceed.
Vivet receives EUR 4.9 million to advance development of a gene therapy
Vivet Therapeutics Announces Presentations at Upcoming European Society of Gene and Cell Therapy (ESGCT) 2023 Annual Congress Paris, France, October 23, 2023 (GLOBE NEWSWIRE) “ Vivet Therapeutics...
Vivet Therapeutics (Vivet), a clinical-stage biotechnology company, and Pfizer Inc. announced the US Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need.
Vivet Therapeutics (Vivet), a clinical-stage biotechnology company, and Pfizer Inc. announced the US Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need.
Compelling additional preclinical data further support therapeutic potential of gene therapy product to treat Progressive Familial Intrahepatic Cholestasis Type 3 (PFIC3).
FOSTER CITY, Calif. & PARIS--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) and Vivet Therapeutics (“Vivet”) announced today an agreement whereby Mirum has the exclusive option to develop and subsequently commercialize Vivet’s two proprietary AAV gene therapy programs for progressive familial intrahepatic cholestasis (PFIC), subtypes 3 and 2. The two programs, VTX-803 and VTX-802, are currently being evaluated in preclinical studies by Vivet, a privately-held gene therapy biotechnology company.
PARIS & NEW YORK--(BUSINESS WIRE)--Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that they have entered into a manufacturing agreement, under which Pfizer will provide clinical supply for a Phase 1/2 clinical trial evaluating Vivet’s proprietary, investigational gene therapy, VTX-801, for the potential treatment of Wilson disease, a rare and potentially life-threatening liver disorder. The trial is expected to commence in early 2021. Terms of the agreement were not disclosed.
PARIS--(BUSINESS WIRE)--Vivet Therapeutics announced today that both the Food and Drug Administration (FDA) and the European Commission (EC) have granted Orphan Drug Designation (ODD) for Vivet’s second gene therapy product, VTX-803, for the treatment of Progressive Familial Intrahepatic Cholestasis type 3 (PFIC3). PFIC3 is a rare life-threatening and chronically debilitating condition due to progressive severe liver dysfunction, accompanied by jaundice, portal hypertension, hepatosplenomegaly and failure to thrive. The symptoms of the disease usually appear first in childhood with progressive cholestasis, evolving to hepatic failure, cirrhosis and need for liver transplantation.