ContraVir Pharmaceuticals Receives HBV IND Approval for Tenofovir Exalidex (TXL ™) in the United States
EDISON, N.J., Sept. 11, 2017 -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) Application in the U.S. for its lead HBV compound, TXL™ for the treatment of chronic hepatitis B.
Earlier this year, ContraVir announced that it had completed a Phase 1, multiple dose study in healthy subjects and a Phase 2a, 28 day study in HBV-infected patients. These studies were conducted in Thailand, a country with a high prevalence of chronic HBV infection. Having successfully achieved proof-of-concept, ContraVir intends to expand the TXL™ clinical program and initiate its first US-based clinical trial for TXL™ in the fourth quarter of 2017, pending approval by the Institutional Review Board. The study will enroll patients with severe renal impairment, and thus will generate data which we believe will further support the favorable safety profile of TXL™.
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Published: 11 September 2017
Written by Editor