SAN DIEGO, July 28, 2015 (GLOBE NEWSWIRE) -- Ciclofilin Pharmaceuticals Inc. ("Ciclofilin" or the "Company"), a hepatitis B virus ("HBV") drug developer, announced today its lead antiviral drug candidate demonstrated significantly reduced liver HBV DNA in a transgenic mouse model. The study was conducted by the National Institute of Allergy and Infectious Diseases ("NIAID"), one of the centers within the National Institutes of Health ("NIH").
Ciclofilin's lead drug, CPI-431-32, is a proprietary cyclophilin inhibiting molecule that targets the host, but does not directly target the virus. As such, CPI-431-32 inhibits the virus' ability to hijack the host for propagation. Multiple modes of activity against the HBV life cycle have already been demonstrated for CPI-431-32 utilizing in vitro assays conducted both in-house and in collaboration with Dr. Philippe Gallay of the Scripps Research Institute in San Diego and with partial support of the National Research Council of Canada. These assays have thus far indicated that CPI-431-32 blocks viral entry to hepatocytes and also interferes with other post-entry mechanisms. The findings, announced today, confirm that one of the important post-entry mechanisms blocked by CPI-431-32 is viral replication within the liver.
Two dosing levels of CPI-431-32 were administered to a transgenic HBV mouse model at 10 mg/kg/day and at 50 mg/kg/day for 14 days via oral gavage. Both drug treatment doses were compared to vehicle control. Liver HBV DNA was quantified by densitometric analysis of Southern blots. At 50 mg/kg/day, a statistically significant reduction in liver HBV DNA (p<0.05) was observed compared to the control group. In addition to demonstrating a reduction in HBV replication in the liver, the company also previously disclosed the drug's anti-fibrotic effect. The drug appeared to be well tolerated.
"We continue to be very encouraged by test results for CPI-431-32. Thus far, Ciclofilin's drug has demonstrated multiple modes of activity including, for example, blockade of viral entry into hepatocytes and a reduction of HBV replication. We have also recently shown a significant reduction in fibrosis scores," explained Dr. Robert Foster, the Company's CEO. "We fully anticipate that this drug will continue to display additional modes of activity as further testing is carried out. Taken together, we believe CPI-431-32 will diminish the virus' ability to propagate while mitigating the downstream negative clinical sequelae observed in hepatitis patients."
"This recent data indicates that CPI-431-32 will not only inhibit viral replication, as confirmed with the NIH/NIAID study, but may also suppress expression of certain proteins, including HBsAg, HBx, and may further reduce the formation and stability of cccDNA," added Dr. Philippe Gallay, Professor at the Scripps Research Institute. "HBV remains an urgent healthcare concern and a functional cure is desperately needed. I am pleased to collaborate with Ciclofilin to take on this challenge."
About Ciclofilin:
Ciclofilin is a privately held life sciences company based in San Diego, California, with R&D facilities in Edmonton, Canada. The company's lead drug, CPI-431-32, is uniquely designed to specifically target the host and not the virus. By targeting the host, CPI-431-32 interferes with the necessary cellular components that allow the virus to infect cells, replicate, and to propagate. CPI-431-32 has more than one mode of action; inhibition of viral transport into cells with additional downstream effects on the virus life cycle. In addition to the anti-HBV effects of CPI-431-32, cyclophilin inhibitors, as a class, may also target liver disease (liver inflammation and fibrosis, liver cirrhosis, and hepatocellular carcinoma).
Forward-Looking Statements
This press release contains forward-looking statements, including with respect to the potential of our lead drug CPI-431-32 for the treatment of HBV. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the significance of our preclinical results and potential applications of our compound for the treatment of HBV patients. Statements that are not historical facts are based on our management's current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. These statements speak only as of the date of this release, and are subject to a number of risks, uncertainties and assumptions. Ciclofilin undertakes no obligation to update or revise these statements, except as required by applicable law.