Spring Bank Pharmaceuticals (NASDAQ:SBPH) stops dosing and enrolling patients in its Phase 2b Catalyst trials, which are examining the use of inarigivir soproxil 400mg for the treatment of chronic hepatitis B virus, after observing symptoms consistent with liver injury in a trial of virally suppressed chronic HBV patients.
SBPH slides 17% in premarket trading.
In addition, the company has stopped dosing and enrollment in all other studies of inarigivir in subjects with chronic HBV.
“We stopped dosing and enrolling patients out of an abundance of caution based on laboratory data from virally-suppressed patients in the CATALYST 2 trial,” said Spring Bank President and CEO Martin Driscoll.
The company is investigating and analyzing the data to gain a better understanding of the findings and potential causes thereof and is further evaluating safety data across the almost 100 patients who have received inarigivir at this dose.
Conference call at 8:30 AM ET.
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