Current antiviral drugs have a very narrow spectrum of coverage by selectively inhibiting unique viral proteins. This way, available antivirals provide a “one drug, one bug” solution. This is an inadequate approach as hundreds of viruses cause human disease, while antiviral therapies are approved for fewer than ten. The clinically tested SIT is an innovative host-directed therapy (HDT) for which Kaufmann et al called for in Nat Rev Drug Discov (Host-directed therapies for bacterial and viral infections, Nat Rev Drug Discov 17, 35 2018). SIT boosts the endogenous innate (IFN) response by an attenuated non-pathogenic avian double stranded (ds) RNA virus, the infectious bursal disease virus (IBDV). This way, SIT can restrict multiple viruses by stimulating host factors commonly effective against several viruses.
Our mission is to develop all-oral functional cure for HBV and HCV patients with unmet needs. SIT has been clinically validated in acute HBV (n=20) and acute HCV (n=22) patients, and in 4 advanced patients (2 HBV/2 HCV).
Fig. 1, 2. Representative treatment curves for drug treated (red line) and control patient (blue line) are indicated in the Figure bellow (Fig 1 ALT; Fig 2 bilirubin). Treatment not only speeded up the recovery but prevented the elongated elevation of bilirubin level characteristic of control patient.
Fig. 3. Conventional and SIT therapy of a decompensated chronic HCV patient; ALT enzyme levels declined after conventional IFN + ribavirin + thymosin treatment (1); then, patient became resistant to IFN. SIT was administered three times (2, 3, 4) successfully suppressing ALT levels.
Fig. 4. Cholinesterase activity levels indicating regeneration of the liver in a chronic female HCV patient treated with IBDV.
Since the first Phase 1/2 clinical trial was performed with a conventionally produced virus, which cannot be registered today by FDA or EMA, a new Phase 1 trial is required using a new well-characterized drug candidate, which is now produced by reverse genetics.
The rate of viral spillover from animals into people is accelerating, leading to a nonlinear rise in pandemic risk. Currently, there are no readily available technological countermeasures to these as-yet-undiscovered viruses. The broad-spectrum post-infection SIT platform technology could be leveraged as an emergency remedy for emerging viral diseases.
HepC Therapeutics Inc. (Superinfection) is a privately-held biotechnology firm based in Budapest, Hungary. The Company was founded as an Ltd in 2005 and converted to incorporation in 2014. Shortly after its foundation, HepC Therapeutics Inc. (Superinfection) has established a strategic alliance with VectorLogics, Inc. (VLI) in the USA. Based upon the IBDV technology (see below) and science VLI has raised almost $400 thousand from grants and invested its own scientific know-how to progress the project. Since VLI’s merger with DNAtrix, Inc. in 2012, the VLI IBDV vector portfolio was transferred to ImiGene, Inc. of Delaware, USA. Superinfection has acquired the IBDV vector portfolio and know-how under a new licensing agreement with ImiGene for equity stake in Superinfection. Superinfection’s USA business office is now located in Rockville, Maryland.
Superinfection is a biotechnology company focused on the development and commercialization of antiviral biologic products. Its lead clinical program is targeting advanced chronic HBV patients in order to provide functional cure during a finite course of treatment that would prevent the development of HCC. Furthermore, we are targeting HBV/HCV co-infected patients in order to treat HCV hepatitis without reactivation of HBV replication. Around 200.000 to 400.000 HBV/HCV coinfected individuals are in the United States alone but many millions worldwide. The SIT platform technology could also mitigate the world-changing effects of the next flu pandemic, for which we aren’t ready to keep the world safe.
 Gish RG: HBV/HCV Coinfection and Possible Reactivation of HBV Following DAA Use. Gastroenterol Hepatol (N Y) 2017, 13:292-295.