Santa Cruz, CA, July 2018 - SomaGenics, Inc. announces the award of a three-year, $2.9 million NIH grant in support of its Hepatitis Delta Virus (HDV) therapeutic program under Principal Investigator and SomaGenics CEO Brian H. Johnston, Ph.D. This Phase II grant, from the NIH’s Small Business Innovation Research (SBIR) program, continues the development of SomaGenics’ novel RNA interference (RNAi)-based approach under a Phase I SBIR grant and will fund late-stage preclinical studies and preparations for clinical trials.
HDV infection, which requires concurrent or prior infection with the hepatitis B virus, results in the most severe form of viral hepatitis, and no HDV-specific therapy exists. Chronic HDV has a 20% mortality rate and its incidence is rising globally. The establishment of U.S.–based Hepatitis Delta Connect (hepconnect.org), a public outreach program, highlights recent efforts to increase patient and physician awareness about the pressing need for HDV screening and treatment.
SomaGenics’ HDV therapeutic is a novel treatment modality simultaneously targeting the virus at multiple stages of its life cycle using the Company’s proprietary synthetic short hairpin RNA (sshRNA®) technology. “Current clinical treatments suffer from multiple problems including limited efficacy, high relapse rate and toxicity,” according to Anne Dallas, Ph.D., Principal Scientist.
To date, the Company has demonstrated efficacy of its sshRNA® HDV therapeutic in cell culture models and will use the new NIH funding to support efficacy studies in animal models as well as to optimize the Company’s novel delivery platform. “Our combination, multi-target approach reduces the likelihood of treatment resistance and targets non-host entities, lowering the chance of toxicity. We are excited that SomaGenics’ therapeutic may have the potential to cure HDV patients,” explains Dr. Dallas.
Somagenics’ sshRNAs® are highly potent RNAi triggers, with IC50’s in the low picomolar range. sshRNAs® have distinct advantages over the more familiar siRNAs, including the fact that they consist of single chemical entities, simplifying their production and purification, and their lack of off-target effects from "passenger" strand retention. sshRNAs® are suitable for use in many indications in addition to HDV, with therapeutics currently in development for chronic wound healing including diabetic foot ulcers.