*Results from full 24 weeks of dosing from the first three cohorts of the ongoing Phase 2 ACHIEVE trial in hepatitis B to be highlighted
*New data from ACHIEVE trial demonstrates that increased baseline serum IP-10, a marker of immune activation in HBV, is a positive predictor for anti-viral response to inarigivir
HOPKINTON, Mass., Nov. 09, 2018 (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 that principal investigators for the ongoing Phase 2 ACHIEVE trial examining the use of inarigivir soproxil for the treatment of chronic hepatitis B virus (HBV) will present additional inarigivir results in two presentations, one oral presentation and one poster of distinction, at the American Association for the Study of Liver Disease (AASLD) conference (The Liver Meeting®) held from Nov. 9-13, 2018 in San Francisco. Spring Bank is developing inarigivir, an orally-administered selective immunomodulator, as a potential backbone in a combinatorial treatment for chronic HBV, with a goal to accelerate and substantially increase functional cure rates in a simple, safe and selective manner.
In the poster of distinction presentation titled Inarigivir is a Novel Selective Inhibitor of the HBV Replicase Complex In Vitro, Professor Stephen Locarnini, Head of Research & Molecular Development at the Victorian Infectious Diseases Reference Laboratory and Principal Investigator of the Virology Core for the ACHIEVE trial, will present data on the direct acting anti-viral (DAA) effect of inarigivir on HBV viral replication. In vitro studies in HBV cell culture systems have demonstrated that inarigivir has the ability to prevent viral replication by inhibiting HBV replication at the level of reverse transcription and/or blocking priming or subsequent primer translocation within the viral nucleocapsid, which appears independent of the RIG-I mediated activation of IRF-3 and cytokine activation. “The unique and novel DAA effect of inarigivir involves its interaction with the pregenomic RNA without preventing encapsidation like a core protein allosteric modulator (CpAM) or chain termination as seen with nucleoside/nucleotide inhibitors,” stated Professor Locarnini. “This inarigivir DAA effect and the RIG-I mediated immune activation have the potential to enhance anti-viral efficacy with both CpAMs and nucleotide/nucleoside inhibitors, and we await further clinical studies.”
In the oral presentation titled Inarigivir Demonstrates Potent Dose Dependent Anti-Viral Activity in HBV Treatment-Naïve Patients: Role of HBeAg Status and Baseline HBsAg in Anti-Viral Response, Professor M.F. Yuen, Chief of Gastroenterology and Hepatology, University of Hong Kong, and Principal Investigator for the ACHIEVE trial, will show the full 24-week clinical and virological data from the 25mg, 50mg and 100mg cohorts of inarigivir monotherapy, including sequential dosing data following the switch from inarigivir to tenofovir disoproxil fumarate (Viread®). The data demonstrate a dose dependent potent anti-viral effect of inarigivir on HBV DNA with reduction of up to 2.75log10 at inarigivir 100mg and similar reductions in HBV RNA. Professor Yuen’s presentation will also highlight the reduction in HBsAg in 13 predefined (HBsAg reduction > 0.5log10) responder patients (7 HBeAg negative, 6 HBeAg positive) with a mean reduction of 0.8log10 (range 0.5log10 – 1.4log10). Predictive factors for anti-viral response to inarigivir monotherapy include HBeAg negative status, baseline HBsAg concentration, baseline serum IP-10 and reduction in IP-10 during the first 12 weeks of inarigivir monotherapy.
“The dose dependent anti-viral response to inarigivir has continued through the 100mg daily dose cohort and the HBsAg reduction in almost 30% of patients treated in the first three cohorts is unique to inarigivir amongst approved and investigational oral HBV anti-virals. Interestingly, new data from the ACHIEVE trial on predictors provides evidence that HBsAg burden ( > 4log10), a key inhibitor of the immune response, reduces anti-viral efficacy and that increased serum IP-10, a marker of immune activation in HBV, is a positive predictor for anti-viral response as previously reported for interferon therapy,” stated Professor Yuen.
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 selectively activate within infected 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 (Stimulator of Interferon Genes) 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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary data that Spring Bank reports 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, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 20, 2018 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
Source: Spring Bank Pharmaceuticals