Dynavax Reports Positive Phase 1b Data for SD-101 in Chronic Hepatitis C Infection
News Feb 01, 2010
Dynavax Technologies Corporation announced data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection.
The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist is well tolerated and safe and induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity.
The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.
Data from the Phase 1b study of SD-101 in treatment-naive, genotype 1 HCV patients show:
• A safety and tolerability profile that compares favorably to that of IFN-alpha, at all four doses tested;
• A dose-dependent antiviral response, with 100% of patients at the highest dose experiencing a greater than one (1) log reduction in viral load; and
• The potency of SD-101 as confirmed by biomarker analysis in patients;
• The biomarker data point to substantial, dose-related increases in the expression of key antiviral genes (MX-B and ISG-54k) and genes indicating enhanced immunity (IP-10 and MCP-1).
The Phase 1b study evaluated four dose levels of SD-101 in 34 chronically infected, treatment-naive, genotype 1 HCV patients. SD-101 was administered as a monotherapy once weekly, for four weeks, in doses from 0.1 to 5.0 milligrams per week.
The in vitro data from a study of the drug in human blood cells demonstrate that compared to first-generation TLR9 agonists, SD-101 stimulates 20-fold higher levels of both IFN-alpha and IFN-lambda, two classes of IFNs with potent activity against HCV.
According to the Company's Chief Medical Officer, J. Tyler Martin, M.D., "The unique and highly potent pattern of IFN-lambda and IFN-alpha induction by SD-101 represents a novel, differentiated approach for HCV. The safety and antiviral activity demonstrated in this Phase 1b study compares favorably to current treatments, and we believe that further study may support a role for SD-101 as a supplement to current or emerging therapies to treat HCV."
With the completed acquisition of Symphony Dynamo earlier this month, Dynavax has full development and commercialization rights to SD-101. As such, SD-101 has been added to a portfolio of development programs available for partnership from Dynavax.
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