Spring Bank Announces Interim Top-Line Results from the First Cohort of the Phase 2 Trial Evaluating Low-Dose Inarigivir Plus Vemlidy® in Chronic Hepatitis B Patients
HOPKINTON, Mass., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc., (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced interim top-line results at 12 weeks from the first cohort of the ongoing Phase 2 trial evaluating the safety, efficacy and pharmacodynamics of escalating doses (50mg, 200mg and 400mg) of the investigational compound inarigivir co-administered with Gilead Sciences, Inc.’ Vemlidy® (tenofovir alafenamide 25mg) for the treatment of chronic hepatitis B virus (HBV) infection. This is the first data from a clinical trial examining the co-administration of inarigivir with a nucleoside analog (NUC) in chronic HBV patients.
“We are impressed by the top-line results from the first cohort of the clinical trial examining the co-administration of the low dose of inarigivir 50mg and the nucleoside analog, Vemlidy®,” said Martin Driscoll, chief executive officer of Spring Bank. “We are very encouraged that these preliminary results suggest the addition of a low dose of inarigivir to a NUC therapy in chronic HBV patients could enhance the size of the HBsAg responder population as compared to the experience with the 50mg monotherapy dose in our completed Phase 2 ACHIEVE dose escalation trial. We look forward to the data from the higher dose cohorts of this trial and our ongoing CATALYST Phase 2b studies evaluating longer durations of treatment with inarigivir monotherapy and co-administered with a NUC that could further expand the chronic HBV responder population with the goal to significantly elevate functional cure rates for HBV patients.”
In this Phase 2 trial, 30 patients with HBV infection received low-dose inarigivir 50mg plus Vemlidy for 12 weeks and 12 patients with HBV infection received Vemlidy alone for 12 weeks. Both arms will continue to receive Vemlidy alone for an additional 36 weeks. Interim top-line results from the first cohort indicate that, at week 12, 7 of the 30 patients in the inarigivir 50mg plus Vemlidy arm were HBsAg responders and met the primary efficacy study endpoint of having greater than or equal to 0.5 log₁₀ IU/mL reduction in HBsAg from baseline. When excluding patients showing signs of an ALT flare prior to entering the study, 5 of the remaining 28 patients in this arm were HBsAg responders at week 12. In the inarigivir 50mg monotherapy cohort of the completed Spring Bank Phase 2 ACHIEVE trial, only 1 of 14 patients was a HBsAg responder at week 12.
In the Vemlidy arm of this Phase 2 trial, 3 of the 12 patients were HBsAg responders. When excluding patients showing signs of an ALT flare prior to entering the study, only 1 of the remaining 10 patients in this arm was a HBsAg responder at week 12.
The co-administration of inarigivir 50mg and Vemlidy was generally safe and well tolerated with no serious adverse events observed over the 12-week treatment period. Treatment-emergent adverse events ranged from mild to moderate in severity.
Further analysis of the inarigivir 50mg plus Vemlidy cohort and evaluation of the safety, efficacy and pharmacodynamics of escalating doses of inarigivir (200mg and 400mg) co-administered with Vemlidy in HBV patients are ongoing. Interim top-line results from the remaining cohorts of the trial are expected in 2020.
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.
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. These statements include, but are not limited to, statements about the clinical and therapeutic potential of inarigivir and the timing of the release of top-line data from the cohorts evaluating inarigivir (200mg and 400mg) co-administered with Vemlidy. 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: whether preliminary data that is reported herein 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; 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 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