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SBPH Begins Dosing in ACHIEVE Global Phase 2 SB 9200 in HBV
http://www.streetinsider.com/Corporate+News/Spring+Bank+Pharmaceuticals+(SBPH)+Begins+Dosing+in+ACHIEVE+Global+Phase+2+Program+Evaluating+SB+9200+in+HBV/11762916.html
Spring Bank Pharmaceuticals, Inc. (NASDAQ: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and cancer, today announced that it has begun dosing the first cohort of patients in the ACHIEVE global Phase 2 clinical program evaluating SB 9200 in immuno-active, treatment-naïve HBV patients without cirrhosis. SB 9200 is the Company’s novel small molecule nucleic acid hybrid (SMNH) compound being developed as both monotherapy and combination therapy for the treatment of Hepatitis B (HBV) and other viral diseases. The first portion of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) 300 mg for an additional 12 weeks.
“The Phase 2a study is designed to enable the rapid identification of the optimal dose of SB 9200 as monotherapy by evaluating the reduction in HBV DNA and HBsAg at 12 weeks,” said Nezam Afdhal MD, Chief Medical Officer of Spring Bank. “A decline of at least 0.5log in HBsAg levels at week 12 in interferon alfa-based treatments has been shown to be predictive of a subsequent functional cure in HBV. In addition, the study will evaluate the effect of sequential dosing with tenofovir for 12 weeks, following monotherapy SB 9200, for possible synergistic effects on the reduction of HBV DNA and HBsAg.”
This Phase 2a study has an adaptive trial design that will enroll 80 chronically-infected HBV patients between 18 and 70 years of age who will be assigned to one of four dosing cohorts, 25 mg, 50 mg, 100 mg or 200 mg of SB 9200, or placebo, once daily for 12 weeks. All subjects will then receive tenofovir 300 mg once daily for an additional 12 weeks of treatment. The Phase 2b portion of the ACHIEVE program is planned to examine the concomitant use of SB 9200 and tenofovir in 200 HBV patients.
“We are excited to begin our Phase 2 program and further our understanding of the therapeutic efficacy and safety of SB 9200,” said Radhakrishnan (Kris) Iyer, PhD, Co-Founder and Chief Scientific Officer of Spring Bank. “We believe SB 9200 has a dual anti-viral mechanism by interfering with the virus’ ability to replicate while at the same time activating the host cellular proteins RIG-I and NOD2 to cause the induction of intracellular interferon signaling pathways for antiviral defense. An HBV functional cure has remained elusive predominantly because viral clearance requires activation of the immune system. SB 9200 promotes intra-hepatic activation of innate immunity and has the potential to be a backbone immuno-modulator for both current nucleoside/nucleotide therapies and novel agents under investigation.”
“The initiation of ACHIEVE represents an important step forward for our SB 9200 development program, as it is the first human trial to evaluate SB 9200 in chronic Hepatitis B patients,” said Martin Driscoll, Chief Executive Officer of Spring Bank. “We have built the capability to execute global clinical trials and look forward to the future advancement of our product pipeline. We are eager to build upon our Phase 1 findings for SB 9200 in otherwise healthy, non-cirrhotic hepatitis C-infected patients where a potent anti-viral effect was observed via innate immune activation.”
Spring Bank Pharmaceuticals, Inc. (NASDAQ: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and cancer, today announced that it has begun dosing the first cohort of patients in the ACHIEVE global Phase 2 clinical program evaluating SB 9200 in immuno-active, treatment-naïve HBV patients without cirrhosis. SB 9200 is the Company’s novel small molecule nucleic acid hybrid (SMNH) compound being developed as both monotherapy and combination therapy for the treatment of Hepatitis B (HBV) and other viral diseases. The first portion of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) 300 mg for an additional 12 weeks.
“The Phase 2a study is designed to enable the rapid identification of the optimal dose of SB 9200 as monotherapy by evaluating the reduction in HBV DNA and HBsAg at 12 weeks,” said Nezam Afdhal MD, Chief Medical Officer of Spring Bank. “A decline of at least 0.5log in HBsAg levels at week 12 in interferon alfa-based treatments has been shown to be predictive of a subsequent functional cure in HBV. In addition, the study will evaluate the effect of sequential dosing with tenofovir for 12 weeks, following monotherapy SB 9200, for possible synergistic effects on the reduction of HBV DNA and HBsAg.”
This Phase 2a study has an adaptive trial design that will enroll 80 chronically-infected HBV patients between 18 and 70 years of age who will be assigned to one of four dosing cohorts, 25 mg, 50 mg, 100 mg or 200 mg of SB 9200, or placebo, once daily for 12 weeks. All subjects will then receive tenofovir 300 mg once daily for an additional 12 weeks of treatment. The Phase 2b portion of the ACHIEVE program is planned to examine the concomitant use of SB 9200 and tenofovir in 200 HBV patients.
“We are excited to begin our Phase 2 program and further our understanding of the therapeutic efficacy and safety of SB 9200,” said Radhakrishnan (Kris) Iyer, PhD, Co-Founder and Chief Scientific Officer of Spring Bank. “We believe SB 9200 has a dual anti-viral mechanism by interfering with the virus’ ability to replicate while at the same time activating the host cellular proteins RIG-I and NOD2 to cause the induction of intracellular interferon signaling pathways for antiviral defense. An HBV functional cure has remained elusive predominantly because viral clearance requires activation of the immune system. SB 9200 promotes intra-hepatic activation of innate immunity and has the potential to be a backbone immuno-modulator for both current nucleoside/nucleotide therapies and novel agents under investigation.”
“The initiation of ACHIEVE represents an important step forward for our SB 9200 development program, as it is the first human trial to evaluate SB 9200 in chronic Hepatitis B patients,” said Martin Driscoll, Chief Executive Officer of Spring Bank. “We have built the capability to execute global clinical trials and look forward to the future advancement of our product pipeline. We are eager to build upon our Phase 1 findings for SB 9200 in otherwise healthy, non-cirrhotic hepatitis C-infected patients where a potent anti-viral effect was observed via innate immune activation.”
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