(GlobeNewswire) - Spring Bank Pharmaceuticals, Inc. (NASDAQ:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and cancer, today announced that it has begun dosing the first cohort of patients in the ACHIEVE global Phase 2 clinical program evaluating SB 9200 in immuno-active, treatment-nave HBV patients without cirrhosis. SB 9200 is the Companys novel small molecule nucleic acid hybrid (SMNH) compound being developed as both monotherapy and combination therapy for the treatment of Hepatitis B (HBV) and other viral diseases. The first portion of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread) 300 mg for an additional 12 weeks.
The Phase 2a study is designed to enable the rapid identification of the optimal dose of SB 9200 as monotherapy by evaluating the reduction in HBV DNA and HBsAg at 12 weeks, said Nezam Afdhal MD, Chief Medical Officer of Spring Bank. A decline of at least 0.5log in HBsAg levels at week 12 in interferon alfa-based treatments has been shown to be predictive of a subsequent functional cure in HBV. In addition, the study will evaluate the effect of sequential dosing with tenofovir for 12 weeks, following monotherapy SB 9200, for possible synergistic effects on the reduction of HBV DNA and HBsAg.
This Phase 2a study has an adaptive trial design that will enroll 80 chronically-infected HBV patients between 18 and 70 years of age who will be assigned to one of four dosing cohorts, 25 mg, 50 mg, 100 mg or 200 mg of SB 9200, or placebo, once daily for 12 weeks. All subjects will then receive tenofovir 300 mg once daily for an additional 12 weeks of treatment. The Phase 2b portion of the ACHIEVE program is planned to examine the concomitant use of SB 9200 and tenofovir in 200 HBV patients.
We are excited to begin our Phase 2 program and further our understanding of the therapeutic efficacy and safety of SB 9200, said Radhakrishnan (Kris) Iyer, PhD, Co-Founder and Chief Scientific Officer of Spring Bank. We believe SB 9200 has a dual anti-viral mechanism by interfering with the virus ability to replicate while at the same time activating the host cellular proteins RIG-I and NOD2 to cause the induction of intracellular interferon signaling pathways for antiviral defense. An HBV functional cure has remained elusive predominantly because viral clearance requires activation of the immune system. SB 9200 promotes intra-hepatic activation of innate immunity and has the potential to be a backbone immuno-modulator for both current nucleoside/nucleotide therapies and novel agents under investigation.
The initiation of ACHIEVE represents an important step forward for our SB 9200 development program, as it is the first human trial to evaluate SB 9200 in chronic Hepatitis B patients, said Martin Driscoll, Chief Executive Officer of Spring Bank. We have built the capability to execute global clinical trials and look forward to the future advancement of our product pipeline. We are eager to build upon our Phase 1 findings for SB 9200 in otherwise healthy, non-cirrhotic hepatitis C-infected patients where a potent anti-viral effect was observed via innate immune activation.
Viread is a registered trademark of Gilead Sciences, Inc.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid, or SMNH, chemistry platform. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus.
Any statements in this press release about Spring Banks future expectations, plans and prospects, including statements about Spring Banks financial prospects, future operations and sufficiency of funds for future operations, clinical development of Spring Banks product candidates, expectations regarding future clinical trials and future expectations and plans and prospects for Spring Bank and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, 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 Spring Banks cash resources will be sufficient to fund its continuing operations for the periods anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Spring Banks product candidates will advance through the clinical trial process on a timely basis; 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 Banks 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 Banks final prospectus for its initial public offering, which is on file with the SEC, 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 Banks views as of the date hereof. Spring Bank anticipates that subsequent events and developments will cause Spring Banks 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 Banks views as of any date subsequent to the date hereof.
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