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Dosing Initiated in a Phase 1 Study of SB 9200
MILFORD, Mass., May 23, 2013 /PRNewswire/ — Spring Bank Pharmaceuticals, Inc., a biopharmaceutical company developing innovative medicines for the treatment of viral infections, today announced that it has initiated dosing in a Phase I study of SB 9200, its investigational, once daily, oral therapy for the treatment of HCV infection. This study will be conducted in healthy, HCV-infected patients and is designed to assess both the safety and antiviral efficacy of SB 9200. SB 9200 is a first-in-class drug for the treatment of chronic HCV infections and is based on the Company’s proprietary Small Molecule Nucleic Acid Hybrid (SMNH) technology platform. It has a unique mechanism of antiviral action involving the selective activation of the host-immune response in HCV-infected cells.
“The initiation of this clinical trial is an important milestone for our Company,” said Doug Jensen , Spring Bank ‘s CEO. “This trial should not only give us proof of concept in HCV, but also will facilitate the advancement of our technology in other viral diseases such as HBV and RSV.” SB 9200 is the first of a potentially important new class of drug based on Spring Bank ‘s proprietary “SMNH” technology platform. The Phase I clinical trial has been designed to provide a significant amount of data related not only to safety of SB 9200 but also the antiviral activity against multiple HCV genotypes.
“Unlike other classes of drugs for HCV infection 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.” By way of its novel mechanism of action, SB 9200 is ideally suited for combination with other classes of HCV antivirals, including direct-acting antiviral agents (DAA) currently in clinical development. In preclinical studies, SB 9200 has shown synergistic antiviral activity when combined with other anti-HCV compounds and has demonstrated an excellent safety profile. In in vitro studies, the compound has demonstrated potent antiviral activity against multiple HCV genotypes 1a, 1b and 3. Thus, this novel mechanism of action is suggestive of pan-genotypic activity and potentially a high barrier to resistance. Moreover, this novel mechanism of action suggests it could have pan-genotypic activity and potentially a high barrier to resistance. These attributes could lead to the use of SB 9200 as part of an Interferon-free, all-oral regimen for HCV therapy.
The Phase I trial is currently being conducted in Australia with plans to expand into clinical sites in New Zealand. The trial is being conducted in two parts. Part A is a single ascending dose of SB 9200 to evaluate the safety and tolerability of a single oral dose of SB 9200, with 8 treatment naive Genotype 1 patients being enrolled into four sequential cohorts of 2 patients each with increasing doses ranging from 100-800mg. Part B of the study is a randomized, double blind, placebo-controlled multiple ascending dose escalation of once daily doses of SB 9200 once a day for 7-14 days. Part B will enroll approximately 40 HCV patients with 5 dosing cohorts, randomized 6:2 active versus placebo. The final dosing cohort will be in Genotype 2/3 patients to demonstrate pan-genotypic activity. The primary endpoint for both parts of the trial is safety. Secondary objectives include an analysis of dose versus viral load reduction, liver function, safety labs, host immune expression, as well as characterization of plasma and urine pharmacokinetics and assessment of pharmacodynamic activity.
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