Results from a Phase 1 clinical trial evaluating ContraVir Pharmaceuticals' (NASDAQ:CTRV) hepatitis B candidate TXL in eight patients with severe renal impairment and eight patients with normal kidney function showed it to be safe and well-tolerated.
In the renal impairment group, blood concentrations of tenofovir (TFV) from a 50 mg dose of TXL were similar to the TFV exposure levels from a 300 mg dose of Gilead Sciences' Viread (tenofovir disoproxil fumarate). The data imply that no dosing strength adjustments for TXL are needed in patients with compromised renal function.
Additional results will be submitted for presentation at future scientific conferences.
TXL (tenofovir exalidex) is a highly potent prodrug of tenofovir.
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