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Spring Bank Announces Positive Study Results from the Inarigivir ACHIEVE Trial
In the third cohort, 20 patients were randomized; 17 on inarigivir 100mg (13 HBeAg-positive, 4 HBeAg-negative) and 3 on placebo. The primary endpoints, safety and antiviral activity, were achieved at both week 12 (inarigivir monotherapy) and week 24 (following the switch to tenofovir disoproxil fumarate (TDF) 300mg after week 12). Inarigivir was well-tolerated with no serious adverse events observed. Overall, treatment-emergent adverse events ranged from mild to moderate in severity, with no observed interferon-like side effects or clinical or biochemical events above Grade 3. One HBeAg-negative patient on inarigivir alone had an ALT flare >200 IU with reductions in HBV DNA and HBsAg consistent with previously described inarigivir immune flares. Overall, mean HBV DNA reduction at week 12 was 1.0log10, with a mean 0.55log10 reduction in HBeAg-positive patients and a mean 2.26log10 reduction in HBeAg-negative patients, which was significantly superior (t-test: p=0.006) to combined placebo from all groups (n=11). Similar log reductions were seen for the secondary endpoint of HBV RNA reduction, with a mean 0.6log10 reduction in HBeAg-positive patients and a mean 1.4log10 reduction in HBeAg-negative patients. Three patients had a greater than 0.5log10 reduction in HBsAg at either week 12 or week 24. Overall, 13 of 47 (28%) of inarigivir-treated patients in the ACHIEVE trial have had a predefined HBsAg response of 0.5log10 decrease, with a mean decrease in the responder group of 0.8log10 (range 0.5 – 1.4log10) at either week 12 or week 24 after the switch to TDF. Baseline HBsAg level < 10,000 IU (4log10) remains the strongest predictor of response to inarigivir across all cohorts for HBV DNA and HBV RNA reductions irrespective of HBeAg status. This response is consistent with the known role of HBsAg as a down regulator of the host immune response to HBV. Detailed results from this third cohort will be presented at a future medical conference.
“We are excited to see the continued efficacious dose response and the favorable safety profile of inarigivir, including no interferon-like side effects. We are particularly pleased to see a maximum reduction in both HBV DNA and HBV RNA by up to 2.76log10 and 5.0log10, respectively, in this third cohort,” stated
The investigation of inarigivir in combination with tenofovir alafenamide for naïve chronic HBV patients continues in a Phase 2 clinical study being conducted by Gilead. The new second cohort of the study will assess 200mg inarigivir co-adminstered with tenofovir alafenamide, subject to independent regulator assessments of the safety of inarigivir at the 200mg dose. Additionally, a new third cohort has been added to examine the administration of inarigivir 100mg in chronic HBV patients currently treated with nucleoside/tide analogues (a “Nuc-suppressed” population).
The expansion of the inarigivir + tenofovir alafenamide co-administration program allows
Dr. Afdhal continued, “We are happy to expand our clinical trial collaboration with our partners at Gilead. HBV cure will require multiple, innovative therapies, and we are excited that inarigivir is part of a development strategy with Gilead.”
About Inarigivir and the 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, including any results announced to date from Part A of the ACHIEVE Phase 2 trial; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; 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, 2017, which was filed with the Securities and Exchange Commission (
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.