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Spring Bank Pharmaceuticals Announces Positive Top-Line Results from the Second Cohort of Part A of the Phase 2 ACHIEVE Trial
Low Dose of Inarigivir Soproxil (50mg) Monotherapy Demonstrates a Favorable Safety Profile and Significant Dose-Dependent Antiviral Activity, Meeting Both Primary Endpoints
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“We are happy to report that inarigivir 50mg daily for 12 weeks met both primary endpoints of safety and efficacy in the second cohort of the ACHIEVE trial,” stated
The second cohort of the trial consisted of 18 evaluable patients, with 14 in the inarigivir 50mg treatment group (10 HBeAg-positive, 4 HBeAg-negative) and 4 on placebo. Two patients in cohort 2 dropped out due to patient choice at day 1 and week 2, respectively, and are not included in the analysis. Within the inarigivir treatment group, inarigivir was well tolerated, with no serious adverse events observed. Overall, treatment-emergent adverse events ranged from mild to moderate in severity, with no interferon-like side effects, and no clinical or biochemical events above Grade 3 were observed. Alanine aminotransferase (ALT) flares, defined as an increase in ALT above 200 IU/ml, were observed in 2 patients in the inarigivir treatment group, both of whom were HBeAg-positive, and each of whom had a reduction in viral markers consistent with a beneficial immune flare.
Overall, inarigivir demonstrated a statistically significant reduction in HBV DNA at week 12 compared to the combined placebo group (n=8), with a mean reduction of 0.74 log10 in the inarigivir treatment group (unpaired t-test, p=0.0008). HBV DNA reductions were greater in HBeAg-negative patients, with a mean reduction of 1.05 log10 (unpaired t-test, p=0.01) and a mean reduction of 0.61 log10 in HBeAg-positive patients (unpaired t-test, p=0.006), when compared to placebo.
For the secondary endpoint of quantitative reduction in HBV RNA, the inarigivir treatment group (mean reduction of 0.95 log10; unpaired t-test, p=0.03) performed significantly better than placebo (mean increase of 0.48 log10), with the effect more pronounced in HBeAg-negative patients. Additionally, when comparing the HBV DNA and HBV RNA response between the first cohort (25mg) and the second cohort (50mg), the second cohort showed a dose-dependent doubling of the mean decline. For the secondary endpoint of quantitative reduction in HBV surface antigen (HBsAg), one HBeAg-positive patient in the inarigivir treatment group had a sustained greater than 0.5 log10 reduction in HBsAg. All 4 HBeAg-negative patients had undetectable HBV RNA at week 12, but no major reduction in HBsAg, suggesting that the patients’ HBsAg may have come from predominantly integrated HBV DNA.
When analyzing the combination of patients in both cohorts 1 and 2 of the ACHIEVE trial, the primary endpoint of HBV DNA reduction stratified for baseline viral load ( < or > 6 log10) or HBsAg level ( < or > 4 log10) demonstrated a significant positive correlation between HBV DNA reduction and lower initial viral burden, independent of HBeAg status.
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 chronic 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 (formerly SB 9200) 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 plans to disclose additional results from the second inarigivir monotherapy dosing cohort at a future medical conference, (ii) the Company’s anticipated timeline for initiating Part B of the Phase 2 ACHIEVE trial, (iii) the Company’s anticipated timeline for reporting top-line data from the third cohort of Part A of the Phase 2 ACHIEVE trial, and (iv) the Company’s expectations for when Gilead will initiate the Phase 2 co-administration trial examining inarigivir and Vemlidy®.
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, including the top-line results from the 50mg cohort of Part A of the ACHIEVE Phase 2 trial; whether the top-line data
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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Source: Spring Bank Pharmaceuticals, Inc.