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Spring Bank Announces Dosing of Inarigivir 400mg In Multiple HBV Studies
- First Patient Dosed Ahead of Schedule in Inarigivir 400mg CATALYST 2 Trial
- First Patient Completes Dosing in Inarigivir 400mg Intra-Hepatic Liver Biopsy Study
- Ongoing Inarigivir + Tenofovir Alafenamide 25mg Co-Administration Trial Expanded to Include Inarigivir 400mg Cohort
Spring Bank’s broad phase 2 HBV clinical development program is designed to demonstrate the likelihood of functional cure in both HBV treatment-naïve and HBV suppressed patients on nucleotide treatment in the CATALYST 1 and CATALYST 2 trials, leading to the potential to initiate inarigivir Phase 3 studies in late 2020. Spring Bank anticipates that it will begin dosing patients in the CATALYST 1 trial, a study examining the use of inarigivir 400mg as monotherapy and co-administered with tenofovir alafenamide 25mg daily in HBV treatment-naïve patients, in September.
“Working with our global investigators, we have been able to dose the first patients in our inarigivir 400mg CATALYST 2 clinical trial much sooner than we had planned,” said
The principal investigator has successfully randomized and completed treatment in the first patient in the intra-hepatic liver biopsy study. This trial will evaluate both the immunology and virology of HBV directly in the liver and the corresponding response to inarigivir. “This exciting and unique study has the potential to determine how activating the innate immune system with inarigivir can reduce intra-hepatic viral burden and cccDNA reservoirs and is a critical scientific study for understanding the pathway to HBV cure,” said Dr.
Additionally, the ongoing collaborative trial examining multiple ascending doses of inarigivir co-administered with tenofovir alafenamide 25mg for 12 weeks has been expanded to include a new cohort of chronic HBV patients receiving inarigivir 400mg daily with tenofovir alafenamide 25mg daily. “The results of this study and our CATALYST trials will enable
In addition, there is an ongoing Phase 2 trial examining the co-administration of inarigivir 50mg and tenofovir alafenamide 25mg in chronic HBV patients, the co-administration of inarigivir 200mg and tenofovir alafenamide 25mg in chronic HBV patients, the co-administration of inarigivir 400mg and tenofovir alafenamide 25mg in chronic HBV patients and the administration of inarigivir 100mg in virally-suppressed patients who currently are and continue to be treated with a NUC. Preliminary data from this trial is anticipated to be presented at a scientific conference in the fourth quarter of 2019.
Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs. For example, there can be no guarantee that any product candidate will be successfully developed or complete necessary preclinical and clinical phases, that the results of any clinical study will be predictive for other clinical studies of the same product candidate, or that development of any of product candidates will successfully continue. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including: whether preliminary data reported by
In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof.
Source: Spring Bank Pharmaceuticals, Inc.