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Spring Bank Pharmaceuticals Commences Multiple Ascending Dose (MAD) Stage of Phase 1 clinical in HCV Patients
Milford, November 26, 2013.
Spring Bank Pharmaceuticals, Inc. of Milford, MA today announced the completion of the single ascending dose portion of their Ph. 1 clinical trial in healthy HCV infected patients and the start of the first cohort of the multiple ascending dose portion of the Phase 1 clinical trial in HCV patients. The trial is being conducted in Australia and New Zealand.
The single ascending dose (SAD) stage of the trial was designed to demonstrate the safety and antiviral activity of a single dose of SB 9200 at 100, 200, 400 and 800 mg once per day in treatment naïve HCV infected patients. 8 patients received SB 9200, 2 patients per dose. Single doses of SB 9200 were well tolerated with no interferon like side effects and no SAEs attributable to SB 9200. Evidence of antiviral activity was observed.
The multiple ascending dose (MAD) stage of the trial is designed to show the safety, PK and antiviral activity of daily doses of SB 9200 for seven days in treatment naïve HCV patients. The MAD stage of the trial is designed to evaluate pan-genotypic activity of SB 9200. The results of this Phase 1 PK/PD study will be used to design Phase 2 studies in HCV as well as HBV patients in 2014.
SB 9200 is an entirely new agent being developed for the treatment of chronic HCV and HBV infections and is based on Spring Bank’s proprietary Small Molecule Nucleic Acid Hybrid (SMNH) technology platform. SB 9200 has a unique mechanism of antiviral action involving the selective activation of the host- immune response in infected cells. “Unlike other classes of drugs for Hepatitis infections that act directly on the virus, SB 9200 targets host cytosolic sensor proteins, RIG-I and NOD2,” states Dr. Kris Iyer, CSO and Co-founder of Spring Bank. “This leads to the selective activation of the host immune response in the presence of viral infection.”
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is engaged in the discovery and development of an entirely new class of safer and more effective medicines based on the Company’s proprietary SMNH, “Small Molecule Nucleic Hybrid” technology program. SB 9200, a potential breakthrough drug for the treatment of HCV and HBV, is the Company’s most advanced drug under development. The Company also has antiviral programs for the treatment of other single and double stranded RNA viruses such as Respiratory Syncytial Virus (RSV), Norovirus and a Broad spectrum antiviral; Spring Bank also has an early anti-inflammatory program targeting Chronic obstructive pulmonary disease (COPD) and Asthma.
Contact: 508-473-5993 Extension 105