Spring Bank Stops Dosing of Inarigivir Patients

Spring Bank Pharmaceuticals announced the company has stopped 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 (HBV). In addition, the company has stopped dosing and enrollment in all other studies of inarigivir in subjects with chronic HBV.

The decision to stop the dosing of inarigivir 400mg in the Phase 2b CATALYST trials was due to clinical findings observed in the CATALYST 2 trial of virally-suppressed chronic HBV patients. Laboratory findings revealed that three subjects participating in this trial showed evidence of hepatocellular dysfunction and an elevation of alanine transaminase (ALT) potentially consistent with liver injury rather than immune flares. 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.

"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. 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. "Working with the members of our Data Safety Monitoring Board, clinical trial investigators and external experts, we will review all of the information available to us from the CATALYST 2 trial and all other inarigivir trials at the 400mg dose to determine the appropriate path forward for these trials."

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