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Spring Bank Pharmaceuticals Announces Top-Line Results from the Initial Cohort of the Phase 2a Segment of the ACHIEVE Trial, a Global Phase 2 Clinical Trial for Chronic Hepatitis B Virus (HBV)
SB 9200 Shows Favorable Safety Profile and Significant Antiviral Activity Against HBV DNA and HBsAg with Initial Low Dose Monotherapy of 25mg
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“We are strongly encouraged by the safety profile of SB 9200 seen in this initial cohort of the Phase 2a trial and by the evidence of antiviral activity seen at the low dose of 25mg daily, because we studied the substantially higher doses of 200mg – 900mg daily for 7 days in our Phase 1 study in HCV patients,” stated
The initial cohort consisted of 11 HBeAg-positive and 9 HBeAg-negative patients, of which 80% were genotype B/C, the most common Asian genotypes. The overall safety profile of SB 9200 was favorable, and over the 12-week study, no serious adverse events were observed. Treatment-emergent adverse events ranged from mild to moderate in severity with no interferon-like side effects and were comparable to patients on placebo. There were no Grade 3 laboratory abnormalities, but alanine aminotransferase (ALT) flares, defined as an increase in ALT above 200 IU/ml, were observed in three patients. Two of these ALT flares were viral flares identified in patients on placebo and the other ALT flare was identified in one patient on SB 9200 at week 4, which was associated with a reduction in HBV DNA of 2.26 log10 and a 1.01 log10 reduction in HBsAg consistent with a beneficial immune flare. Study investigators did not observe any increase in bilirubin or evidence of hepatic decompensation.
Overall, SB 9200 demonstrated a statistically significant reduction in HBV DNA at week 12 (unpaired t-test 2.85, p=0.01) compared to placebo, with a mean reduction of 0.6 log10 (range 0 to 1.87 log10) in the SB 9200 treatment group. For the secondary endpoint of quantitative HBsAg reduction, 5 of 16 patients (31%) in the SB 9200 treatment group had a greater than 0.5 log10 reduction at any time point (range 0.52 to 1.01 log10), compared to none in the placebo group.
The 7 HBeAg-negative patients in the SB 9200 treatment group had the greatest mean reduction in HBV DNA at 0.9 log10, and 3 of these 7 patients also had a greater than 0.5 log10 reduction in HBsAg.
Detailed results from the Phase 2a segment of the ACHIEVE study will be presented at a future medical conference.
About SB 9200 and the ACHIEVE Study
Spring Bank’s lead product candidate, 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 Phase 2a clinical trial is designed to enable
Statements in this press release about Spring Bank’s future expectations, plans and prospects, including, but not limited to, statements about the company’s expectations for the enrollment of patients in the second cohort of the Phase 2a segment of the ACHIEVE trial; the company’s anticipated timeline for disclosing top-line results from the second cohort of the Phase 2a segment of the ACHIEVE trial and the company’s anticipated timeline for initiating the Phase 2b segment of the ACHIEVE trial, 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
In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof.