Spring Bank Pharmaceuticals Inc. stopped dosing and enrolling patients with chronic hepatitis B virus in its phase 2 trials evaluating the 400-milligram dose of inarigivir.
The Hopkinton, Mass.-based biotech in a Dec. 26 press release said that the decision is based on the laboratory observations of a specific phase 2 trial, dubbed Catalyst 2.
Findings from the tests showed evidence of liver dysfunction and a rise in alanine transaminase — an enzyme found in kidney and liver cells — consistent with liver injury in three patients with chronic HBV who were given a 400-milligram dose of inarigivir under the mid-stage study.
Additionally, given the findings, Spring Bank is evaluating the drug's safety in about 100 patients receiving inarigivir at this dose.
Spring Bank also said it will be working with the members of data safety monitoring board, clinical trial investigators and external experts regarding this specific drug dose to decide how to further its clinical development.
The 100-milligram dose of inarigivir has previously met its key goals of safety and antiviral activity in another mid-stage study evaluating patients with chronic HBV.