26.12.2019 12:19:15
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Spring Bank Stops Dosing Of Inarigivir Patients In Chronic HBV Trial
(RTTNews) - Spring Bank Pharmaceuticals Inc. (SBPH) said that it stopped the dosing of inarigivir 400mg in the Phase 2b CATALYST trials, due to clinical findings observed in the CATALYST 2 trial of virally-suppressed chronic hepatitis B virus patients.
Laboratory findings revealed that three subjects participating in this trial showed evidence of hepatocellular dysfunction and an elevation of alanine transaminase or ALT potentially consistent with liver injury rather than immune flares.
"... We are certainly disappointed to stop our current Phase 2 inarigivir trials, but ensuring patient safety and care is of paramount importance to us," said Martin Driscoll, president and chief executive officer of Spring Bank.
Phase 2b CATALYST trials were examining the use of inarigivir soproxil 400mg for the treatment of chronic hepatitis B virus (HBV). In addition, the company stopped dosing and enrollment in all other studies of inarigivir in subjects with chronic HBV.
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