Inarigivir Phase 2 results confirm antiviral activity & novel mechanism of action
Data Safety Monitoring Board approves proceeding with enrollment of third cohort (inarigivir 100mg) of the ACHIEVE trial
HOPKINTON, Mass., Oct. 20, 2017 (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 data on its lead candidate inarigivir soproxil (formerly referred to as SB 9200) from two key presentations at the American Association for the Study of Liver Disease (AASLD) conference (The Liver Meeting®) held on Oct. 20-24, 2017 in Washington, D.C.
In the first presentation, Professor M.F. Yuen, Chief of Gastroenterology at Hong Kong University and one of the Principal Investigators for the Phase 2 ACHIEVE trial, will highlight in an oral presentation additional data from the first cohort of patients in Part A of the ACHIEVE trial where treatment-naïve patients with chronic hepatitis B (HBV) without cirrhosis received the low monotherapy dose of 25mg of inarigivir once-daily over a 12-week period. At the conclusion of this inarigivir 25mg monotherapy dosing period, all of the patients, including those who received placebo, were switched to tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) 300mg dosed once-daily for 12 weeks. Results from the 12 week inarigivir 25mg monotherapy dosing period demonstrated that inarigivir had a significant antiviral effect on both HBV DNA and HBsAg and was well-tolerated with a favorable safety profile. Additionally, the data demonstrated that switching patients from inarigivir to 300mg daily of Viread for 12 weeks following the 12 weeks of inarigivir 25mg monotherapy was associated with further declines in HBsAg, particularly in HBeAg-positive patients.
“The results from this first cohort demonstrate the promise and potency of inarigivir as a novel antiviral and immunomodulatory agent for the treatment of chronic HBV as we strive for a functional cure in our patients,” said Professor Yuen.
In the second presentation, a late-breaker poster presentation, 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 discuss results from the first cohort that demonstrate the effects of 25mg of inarigivir on key virological parameters such as HBsAg, HBV RNA, HBcrAg and associated serological evidence of immune recovery. Key findings include significant declines induced by inarigivir in HBV DNA, HBsAg, HBV RNA and HBcrAg, which together indicate a potent antiviral effect at this low dose of inarigivir, which was highly prevalent in HBeAg-negative patients.
“The dramatic reductions in HBV RNA and HBcrAg and associated changes in key epitopes of HBsAg point to a significant and novel antiviral effect of low dose inarigivir on key HBV functions, including pgRNA encapsidation and potentially the transcriptional activity of cccDNA,” said Professor Locarnini.
Following these presentations, a copy of presentation materials can be accessed by visiting the Investors & Media section of the company’s website at www.springbankpharm.com.
The ACHIEVE Trial
The Phase 2 ACHIEVE trial is ongoing in Hong Kong, Taiwan, Korea and Canada. The second cohort of Part A of the ACHIEVE trial involving the monotherapy dosing of 50mg inarigivir has been completed. The Data Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring Spring Bank’s ACHIEVE trial, has reviewed the initial safety and tolerability data from patients in the 50mg monotherapy dose cohort in Part A of the ACHIEVE trial of inarigivir. Based on their recent assessment of this safety data, the DSMB approved proceeding with the enrollment for the third cohort of the ACHIEVE trial with a dose escalation to 100mg once a day. Study investigators have already begun screening patients for the third cohort of the ACHIEVE trial, which will also enroll 20 patients.
About Spring Bank
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 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, inarigivir (formerly referred to as SB 9200), for the treatment of viral diseases, including hepatitis B virus (HBV) and 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.
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 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 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, Spring Bank's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which was filed with the SEC on July 31, 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.
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