US-based Spring Bank Pharmaceuticals has started the first cohort of the multiple ascending dose (MAD) portion of the Phase I HCV clinical trial that is being conducted in Australia and New Zealand.
The company has recently completed the single ascending dose (SAD) portion of their Phase I clinical trial in healthy HCV infected patients.
The SAD portion of the trial was designed to show the safety and antiviral activity of a single dose of SB 9200 at 100mg, 200mg, 400mg and 800mg once a day in treatment-naive HCV-infected patients.
In this phase of the trial, eight patients were given SB 9200 with two patients per dose, which showed SB 9200 was well-tolerated with no interferon-like side effects and no SAEs attributable.
The MAD stage of the trial is designed to show the safety, pharmacokinetics and antiviral activity of daily doses of SB 9200 for seven days in treatment naive HCV patients, as well as assess pan-genotypic activity of SB 9200.
The results of this Phase I pharmacokinetics/pharmacodynamics trial will be used to design Phase II studies in HCV as well as HBV patients in 2014.
Based on the company’s Small Molecule Nucleic Acid Hybrid (SMNH) technology platform, SB 9200 is being developed for the treatment of chronic HCV and hepatitis B virus (HBV) infections.
It has a unique mechanism of antiviral action involving the selective activation of the host- immune response in infected cells.
Spring Bank CSO and co-founder Kris Iyer said 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.
"This leads to the selective activation of the host immune response in the presence of viral infection," Iyer added.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of TimVickers.