ContraVir Pharmaceuticals Receives HBV IND Approval For Tenofovir Exalidex In The U.S.

- Sep 13, 2017 -

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FDA has approved ContraVir Pharmaceuticals' (NASDAQ:CTRV) 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 completed a Phase 1 and a Phase 2a, 28 day study in HBV-infected patients in Thailand. 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 Q4, pending approval by the Institutional Review Board in patients with severe renal impairment.


Tenofovir exalidex (TXL) is a highly potent prodrug of the antiviral tenofovir.  Tenofovir is the active component of both Vemlidy (tenofovir alafenamide) and Viread (tenofovir disoproxil fumarate).


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source:seeking alpha