MILFORD, Mass., April 13, 2015 /PRNewswire/ -- Spring Bank Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, today announced two poster presentations on SB 9200, its lead drug candidate for the treatment of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections, at The International Liver Congress™ 2015, 50th annual meeting of the European Association for the Study of the Liver (EASL), taking place April 22-26, in Vienna, Austria.
"We are very pleased to have been selected to present our HBV preclinical data and HCV Phase I data at the upcoming EASL meeting," said Radhakrishnan (Kris) Iyer, Ph.D., Chief Scientific Officer of Spring Bank. "This congress affords us the opportunity to highlight our drug development programs in two difficult-to-treat viral infections to the worldwide medical and scientific communities."
Details of Spring Bank's presentations are below:
Poster Presentation
Title: Antiviral Efficacy and Induction of Host Immune Responses with SB 9200, an Oral Prodrug of the Dinucleotide SB 9000, in the Woodchuck Model of Chronic Hepatitis B Virus (HBV) Infection
Date and Time: Saturday, April 25, 2015, 12:30 pm – 1:00 pm CEST
Location: Hall B ePoster Area
Abstract Number: P0636
Session Info: Viral hepatitis: Hepatitis B & D – c. Clinical (Therapy, new compounds, resistance)
An oral presentation of the poster will also be made by Dr. Stephan Menne, Research Associate Professor at the Department of Microbiology & Immunology, Georgetown University Medical Center
Date and Time: Saturday, April 25, 2015, 12:30 pm – 1:00 pm CEST
Location: Hall B ePoster Area
ePoster screen: C-01
Late Breaker
Title: SB 9200, A Novel Immunomodulator for Patients with Viral Hepatitis: Phase 1 MAD Study in patients with Hepatitis C Virus (HCV) Infection
Date and Time: Saturday, April 25, 2015, 3:30 pm – 4:00 pm CEST
Location: Hall B ePoster Area
About European Association for the Study of the Liver (EASL)
Since 1966, when the association was founded, EASL has continued to grow from a small organisation that played host to 70 participants at its first meeting, to becoming the leading liver association in Europe. EASL attracts the foremost hepatology experts as members and has an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policies. For more information about EASL, please visit https://ilc-congress.eu/.
About SB 9200
SB 9200, derived from Spring Bank's proprietary Small Molecule Nucleic Acid Hybrid (SMNH) technology platform, is a novel anti-viral agent that uniquely acts by modulating the host immune response to viral infections through activation of the intracellular sentinel proteins RIG-I and NOD2. SB 9200 is being developed for the treatment of chronic hepatitis B and C and other viral infections.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is a clinical stage biopharmaceutical company. Based on its proprietary SMNH chemistry platform, Spring Bank is developing a pipeline of products representing a new class of pharmaceuticals with a wide range of applications. These rationally designed molecules combine the selectivity of naturally occurring nucleotides with the drug-like properties of classical pharmaceuticals. The SMNHs have the properties of oral delivery, good pharmacokinetic profile, low side effects and ease of manufacture. The Company's most advanced clinical candidate, SB 9200, is a potential breakthrough drug for the treatment for HBV, HCV and other viral diseases. SB 9200 has a novel mechanism of action that involves modulation of the host immune response in the presence of viral infection.
Note Regarding NIH-Funded Research
Certain studies mentioned in this press release were partly supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01AI094469 and NIAID contract laboratories. The content of this press release is solely the responsibility of Spring Bank Pharmaceuticals and does not necessarily represent the official views of the National Institutes of Health.
Contact:
Douglas J. Jensen
President and Chief Executive Officer, Spring Bank Pharmaceuticals
(508) 473-5993 x105
P0636
ANTIVIRAL EFFICACY AND INDUCTION OF HOST IMMUNE
RESPONSES WITH SB 9200, AN ORAL PRODRUG OF THE
DINUCLEOTIDE SB 9000, IN THE WOODCHUCK MODEL OF
CHRONIC HEPATITIS B VIRUS (HBV) INFECTION
K. Korolowicz1, S. Czerwinski1, R. Iyer2, J. Skell2, J. Yang1, R. Tucker3,
S. Menne1. 1Microbiology and Immunology, Georgetown University
Medical Center, Washington, DC, 2Spring Bank Pharmaceuticals,
Milford, MA, 33Department of Comparative Medicine, Georgetown
University Medical Center, Washington, DC, United States
E-mail: [email protected]
Background and Aims: Activation of the viral sensor proteins, RIG-I
and NOD2, by viral nucleic acids results in the production of type I
IFNs and subsequent induction of ISGs and antiviral immune cells.
SB 9200, an oral prodrug of the dinucleotide SB 9000, activates
RIG-I and NOD2 by binding at the nucleotide binding domain of
both proteins. This interaction also inhibits the synthesis of viral
nucleic acids by steric blockage of the viral polymerase. The host
immune stimulating and direct antiviral activities of SB 9200 were
evaluated in the woodchuck model of chronic HBV infection. SB
9200 is being developed for the treatment of chronic hepatitis B
and C and has completed Phase I clinical trials in treatment-naive
HCV-infected patients.
Methods: Two groups of woodchucks with chronic woodchuck
hepatitis virus (WHV) infection (n = 5/group) were treated orally,
daily with SB 9200 for 12 weeks at doses of 15 or 30 mg/kg.
Endpoints included PK, PD, tolerability, and antiviral efficacy.
Results: Treatment with SB 9200 at two select dose levels
resulted in up to 4.2 and 2.2 log10 reductions in serum WHV
DNA or WHV surface antigen (WHsAg) loads, respectively, from
pretreatment level. Treatment was also associated with reduced
hepatic levels of WHV DNA (up to 41%), WHV cccDNA (up to
32%), and WHV RNA (up to 50%), lower hepatic expression of WHV
antigens, and reduced liver disease progression. Following cessation
of treatment, recrudescence of WHV replication was observed
in all woodchucks treated with 15 mg/kg, whereas woodchucks
administered 30 mg/kg had delays in the relapse of serum WHV
DNA and WHsAg. The development of an anti-WHs antibody
response was not observed. The antiviral effects were associated
with a dose-dependent induction of IFNs (IFN-a, IFN-b) and ISGs
(OAS-1, CXCL10, ISG15) in blood and liver. Prolonged SB 9200
administration at both dose levels was well tolerated with CBC,
hematology and serum biochemistry parameters all appearing
normal through the treatment period.
Conclusions: Oral administration of SB 9200 for 12 weeks in
woodchucks with chronic WHV infection resulted in marked
reductions in serum and hepatic levels of viral DNA, RNA, and
antigens that were associated with (or were a result of) the
induction of host immune responses. These results suggest that
SB 9200 can induce an antiviral immune response during chronic
active hepadnaviral infection that has the potential for a functional
cure in the treatment of chronic hepatitis B, most likely in
combination with approved anti-HBV drugs.作者: StephenW 时间: 2015-4-19 13:31