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Spring Bank Stops Dosing of Inarigivir Patients in Phase 2 Program
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
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, about Spring Bank’s future expectations, plans and prospects. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “potential,” “possible,” “hope,” “likelihood” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: Spring Bank’s ability to successfully demonstrate the safety and efficacy of its product candidates; any delay of any current or planned non-clinical or clinical trials or the development of any product candidate; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether the results of such trials will warrant submission for approval from the
In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof.
McNeil, Gray & Rice
Source: Spring Bank Pharmaceuticals, Inc.