- 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
HOPKINTON, Mass., July 23, 2019 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced dosing of patients with inarigivir soproxil 400mg in two significant trials: (1) the CATALYST 2 trial, examining the administration of inarigivir 400mg in nucleo(t)side (NUC)-suppressed chronic hepatitis B virus (HBV) patients, and (2) a unique liver biopsy study examining paired liver biopsies in HBV patients before treatment and on treatment with inarigivir to identify the interaction of inarigivir 400mg with the intrahepatic immune system and its effect on cccDNA. Spring Bank also announces the expansion of a collaborative study in patients infected with chronic HBV involving the evaluation of multiple doses of inarigivir co-administered with tenofovir alafenamide 25mg to include the 400mg dose of inarigivir.
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 Martin Driscoll, president and chief executive officer of Spring Bank. Mr. Driscoll continued, “We have seen the rapid screening of patients in this global trial, which is a strong indication of the need for novel treatments for HBV cure and the excitement of our investigators to further study inarigivir as a potential backbone immunomodulator for HBV cure. We are very excited to see the first patients enrolled and dosed in the two treatment strategy arms of this trial, stopping treatment and then treating with inarigivir on the occurrence of flare and adding inarigivir to treatment patients suppressed with NUC therapy, and we could be in a position to observe evidence of HBV functional cure for inarigivir treatment by the middle of 2020.”
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. Antonio Bertoletti, a member of the Spring Bank Scientific Advisory Board and the Principal Investigator of the study at Duke–NUS Medical School in Singapore.
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 Spring Bank to make a decision on the future strategy for a Phase 3 inarigivir program across multiple patient groups in 2020,” said Mr. Driscoll.
Inarigivir Clinical Development
Spring Bank has launched two Phase 2 global trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administered with a NUC in naïve and virally-suppressed chronic HBV patients. The CATALYST trials include multiple patient cohorts with dosing periods to include 12 weeks, 24 weeks, and 48 weeks. These trials are designed to demonstrate the likelihood of functional cure, and Spring Bank could be in a position to reveal functional cure data from one or more of these trials in 2020.
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.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleotide platform. The company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The company’s lead product candidate, inarigivir, is being developed for the treatment of chronic hepatitis B virus (HBV). Inarigivir is designed to activate within hepatic cells retinoic acid-inducible gene 1 (RIG-I), which has been shown to inhibit HBV viral replication and induce the intracellular interferon signaling pathways for antiviral defense. The company is also developing its lead STING agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers. For more information, please visit www.springbankpharm.com.
Statements in this press release about Spring Bank’s future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the potential of inarigivir as a drug, the company’s expectations for release of functional cure data, the timing of release of data from a collaborative Phase 2 co-administration trial and the company’s expectations for beginning a Phase 3 program for inarigivir. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
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 Spring Bank changes following a more comprehensive review of the data related to the clinical trial and as more patient data become available or as additional analyses are conducted; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Spring Bank’s product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Spring Bank’s Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on March 11, 2019 and in other filings Spring Bank makes with the SEC from time to time.
In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof. Spring Bank anticipates that subsequent events and developments will cause Spring Bank’s views to change. However, while Spring Bank may elect to update these forward-looking statements at some point in the future, Spring Bank specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spring Bank’s views as of any date after the date hereof.
Spring Bank Pharmaceuticals, Inc.
Chief Financial Officer
LifeSci Advisors, LLC
Ashley R. Robinson
McNeil, Gray & Rice
Senior Account Supervisor
Source: Spring Bank Pharmaceuticals, Inc.