Begins Screening Patients for Second Cohort of the Global Phase 2a ACHIEVE Trial
HOPKINTON, Mass., May 15, 2017 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer, and inflammatory diseases, announced today that the Data Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring Spring Bank’s ACHIEVE global Phase 2a clinical trial evaluating SB 9200 in treatment-naïve chronic Hepatitis B virus (HBV) patients without cirrhosis, has reviewed the initial safety and tolerability data from the 25mg monotherapy dose cohort (n=20) in the Phase 2a clinical trial of SB 9200. Based on their assessment of the safety data, the DSMB approved proceeding with the enrollment for the second cohort of the Phase 2a segment of the ACHIEVE trial with a dose escalation to 50mg once a day.
Spring Bank also announced that study investigators have already begun screening patients for the second cohort of the ACHIEVE trial, which will also enroll 20 patients.
“We are encouraged that SB 9200 appeared to be well-tolerated based on the DSMB’s assessment of the data from the first cohort and their authorization to proceed with the second monotherapy dosing cohort,” stated Nezam Afdhal, M.D., chief medical officer of Spring Bank. “We look forward to continuing the ACHIEVE trial and hope to rapidly enroll patients into the second cohort of the Phase 2a segment of the trial.”
SB 9200 is a novel small molecule nucleic acid hybrid (SMNH) compound being developed as both monotherapy and combination therapy for the treatment of chronic HBV. The first segment 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 segment of the ACHIEVE trial has an adaptive trial design that will enroll 80 chronically-infected HBV patients between 18 and 70 years of age who have been or 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 Viread 300 mg once daily for an additional 12 weeks of treatment. The Phase 2b segment of the ACHIEVE trial is designed to examine the concomitant use of SB 9200 and Viread in approximately 200 HBV patients.
Spring Bank anticipates reporting top-line results from the 25mg monotherapy dosing cohort of the ACHIEVE trial in the coming weeks.
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 (SMNH) chemistry platform. SMNH compounds are small segments of nucleic acids that the company designs to selectively target and modulate the activity of specific proteins implicated in various disease states. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus (HBV). SB 9200 has been designed to selectively activate within infected cells the cellular proteins, retinoic acid-inducible gene 1, or RIG-I, and nucleotide-binding oligomerization domain-containing protein 2, or NOD2, which have been implicated in the body's immune response to viral infections. Spring Bank Pharmaceuticals is also developing other SMNH product candidates, including SB 11285, the company’s lead immunotherapeutic agent for the treatment of selected cancers through the activation of the STimulator of INterferon Genes, or STING, pathway. For more information, please visit www.springbankpharm.com.
Any statements in this press release about Spring Bank’s future expectations, plans and prospects, including, but not limited to, statements about the company’s anticipated timeline for disclosing top-line results from the first SB 9200 monotherapy dosing cohort in the Phase 2a trial of SB 9200 and expectations and hopes for the enrollment of patients in the second cohort of the Phase 2a segment of the ACHIEVE trial, as well as any 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 Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis, or at all; 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 any 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, 2016, which was filed with the Securities and Exchange Commission (SEC) on February 14, 2017, 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 subsequent to the date hereof.
Spring Bank Pharmaceuticals, Inc.
Chief Financial Officer
Spring Bank Pharmaceuticals Inc.