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Spring Bank Announces Presentation of Combined Inarigivir 25 mg and 50 mg 12 and 24 Week ACHIEVE Results Demonstrating Enhanced Anti-Viral Efficacy in HBeAg-Negative Patients
Data from the combined first two low dose inarigivir cohorts at weeks 12 and 24 with sequential Viread dosing demonstrate significant reductions in HBV DNA, HBV RNA and HBsAg
Data to be presented at the APASL 2018 Annual Meeting
“Data from the combined first two inarigivir monotherapy cohorts at weeks 12 and 24 demonstrate significant reductions in viral markers, including HBV DNA, HBV RNA and HBsAg, with a favorable safety and tolerability profile,” stated Dr. Afdhal.
The data presented at APASL includes 30 patients treated with inarigivir and 8 placebo patients from the first two low dose cohorts. Potent antiviral response, defined as > 1 log10 reduction in HBV DNA and > 3 log10 reduction (or to undetectable) in HBV RNA at the end of 12 weeks of inarigivir monotherapy treatment, was seen in 8 patients. Additionally, an enhanced anti-viral effect was observed in patients with baseline low viral burden, as measured by HBsAg (<104) and HBV DNA (<106). A dose relationship was observed between the pK and anti-viral efficacy at these initial low doses of inarigivir. Furthermore, the switch at week 12 to tenofovir disoproxil fumarate 300 mg was associated with significant reduction in HBV DNA but, as expected, showed little effect on further reductions in HBV RNA, potentially indicating the important dual mechanism of action of inarigivir as a direct acting anti-viral preventing HBV RNA encapsidation and an immuno-modulator stimulating immune-mediated clearance of cccDNA.
“When we examine the 11 HBeAg-negative patients who received inarigivir 25 mg or 50 mg monotherapy, we see a better response rate than in HBeAg-positive patients, with 55% of patients having a > 1 log10 reduction in HBV DNA and an associated > 3 log10 reduction in HBV RNA at the end of 12 weeks treatment. Additionally, 9 of the 30 (30%) patients had a > 0.5 log10 reduction in HBsAg at either week 12 or week 24 after transitioning to tenofovir disoproxil fumarate, a predictor of HBsAg loss with immune therapies such as interferon, highlighting the potential for inarigivir as a backbone treatment for HBV functional cure,” stated Dr. Afdhal.
As previously reported,
About Inarigivir and the ACHIEVE Trial
Spring Bank’s lead product candidate, inarigivir, is a novel small molecule nucleic acid hybrid (SMNH) compound being developed as both monotherapy and combination therapy for the treatment of HBV. Part A of the Phase 2 clinical trial is designed to enable
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, inarigivir soproxil for the treatment of viral diseases, including hepatitis B virus (HBV).
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. These statements include, but are not limited to, statements about (i) the Company’s expectations relating to the completion of the third cohort (100 mg) and beginning the fourth cohort (200 mg) of Part A of the Phase 2 ACHIEVE trial, (ii) the Company expectations for the release of data from the inarigivir 50 mg + Vemlidy study being conducted by Gilead, and (iii) the Company’s anticipated timeline for initiating Part B of the Phase 2 ACHIEVE trial.
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
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.
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Source: Spring Bank Pharmaceuticals, Inc.