Koronis Pharmaceuticals
Koronis Pharmaceuticals, Inc. (Koronis) has been established to develop technologies for the prevention and treatment of chronic viral diseases, with a particular focus on those caused by the human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
The emergence of resistance to the existing limited number of antivirals and the discovery of one new human viral pathogen every other year in recent decades dictates the significant medical need for novel therapeutics. To address these medical needs, Koronis has acquired rights from the University of Washington to two novel antiviral platforms designed to address the issue of viral resistance that defeat currently approved therapeutics.
The high rate of mutation of viruses allows them to evade conventional therapeutics. However, this high rate has a cost, even a modest increase in the rate has been modeled to extinguish a population. Stealth NucleosidesTM use this high rate to advantage by hypermutating the viral genome. After cumulating a critical number of mutations, the virus is ultimately unable to further replicate. This process is known as Selective Viral MutagenesisTM (SVM) . Patents have been filed and four are issued covering SVM.
Biotechnology in Viral Treatment
Koronis Pharmaceuticals Receives Notice of Allowance on Patent for Novel Therapeutic KP-1461 in Development for Treatment of HIV
Seattle (April 19, 2006) Koronis Pharmaceuticals, Inc. today announced receipt of a notice of allowance from the United States Patent & Trademark Office on a patent application covering KP-1461, the Company s lead product candidate in development for the treatment of HIV.
The allowed claims relate to both use and composition of KP-1461, an oral small molecule currently in clinical trials to treat HIV infection. KP-1461 utilizes a novel therapeutic mechanism, Viral Decay Acceleration™ (VDA), that works by increasing the virus naturally high mutation rate. The accumulation of mutations throughout the viral genome exceeds an error threshold and leads to viral collapse. In vitro experiments have demonstrated the VDA mechanism, and scientists anticipate that similar findings will be noted in clinical trials of HIV-infected patients.
"This patent is quite significant because it is the first on a Viral Decay Acceleration™ molecule. It will be an important addition to our strong patent portfolio, which currently includes five issued patents related to the VDA approach," said Donald Elmer, Chairman and interim chief executive officer of Koronis.
KP-1461 is designed to provide a unique approach to the treatment of HIV infection. Unlike approved antiretroviral agents, KP-1461 does not inhibit viral enzymes or proteins. Rather, by inducing mutations within the viral genome, KP-1461 degrades viral fitness leading to viral population collapse. Preliminary results from the Phase 1b safety and pharmacology trial in therapy-experienced HIV-infected patients have demonstrated KP-1461 to be safe and well tolerated. Based on these results Koronis Pharmaceuticals plans to initiate Phase 2 clinical trials in the second quarter of 2007 in order to demonstrate proof-of-concept for VDA.
Koronis Pharmaceuticals used biotechnology tools such as molecular biology, cell-based testing, and genomic analysis to develop innovative solutions for viral infections like HIV and hepatitis. Through the use of advanced monitoring tools and addressing resistance, Koronis contributed to the development of long-lasting and effective treatments for viral diseases.