SEATTLE, Oct. 12 /PRNewswire/ -- Koronis Pharmaceuticals, Inc. today announced the initiation of a Phase 1b clinical trial of KP-1461, its novel anti-viral therapeutic, in HIV-positive patients. The objectives of the trial are to evaluate the safety, toxicity, pharmacokinetic profile and initial clinical activity of KP-1461. The trial is being conducted at several HIV treatment centers in the United States.
KP-1461 is a first-in-class therapeutic designed to overcome the problem of drug resistance that has emerged with approved HIV treatments. KP-1461 has a novel mechanism of action designed to eliminate the human immunodeficiency virus (HIV) by selectively increasing its natural mutation rate to a point that it can no longer replicate. Unlike currently approved HIV treatments -- enzyme and fusion inhibitors -- that work to block virus activation and replication, KP-1461 targets HIV mutation to force the production of a non-functional virus. This approach, called “Selective Viral Mutagenesis(TM),” may have potential applications to the treatment of other viral diseases.
“KP-1461 is an exciting investigational compound that offers a potential new approach to the treatment of HIV infection,” said Donna Sweet, M.D., clinical investigator and professor of medicine at the University of Kansas School of Medicine. “Unlike currently approved anti-HIV drugs that work to inhibit the HIV-virus by suppressing its replication, KP-1461 is designed to generate a high rate of mutation that is lethal to the virus. We are pleased to be investigating this product candidate in HIV-positive patients.”
The multi-center, randomized, double-blind, placebo-controlled, dose-escalation study is currently open to enroll approximately 40 HIV positive patients who have previously failed highly active antiretroviral (HAART) regimens. Cohorts of 10 patients will be randomized 4:1 to receive KP-1461 or placebo. The dosage of KP-1461 will increase for each patient cohort.
“The development of KP-1461 has evolved from an increased understanding of the genetics of HIV,” said John Reno, Ph.D., chief operating officer of Koronis. “By targeting the natural mutation mechanism of HIV, the process the virus uses to develop drug resistance, and directing that activity toward the eventual destruction of the virus itself, KP-1461 has demonstrated the potential to ablate HIV infection in vitro and was well tolerated in a Phase 1a trial involving healthy subjects. We look forward to the results of this trial and the future development of this product candidate and the Selective Viral Mutagenesis approach with other human pathogenic viruses including hepatitis C virus.”
HIV/AIDS: Current treatments
HIV, the virus that causes Acquired Immune Deficiency Syndrome (AIDS), is currently treated with antiretroviral drugs including reverse transcriptase inhibitors, protease inhibitors and a fusion inhibitor. Because HIV can become resistant to these drugs, treatment consists of combination therapy, using several drugs together, to inhibit the virus effectively. Currently approved drugs do not cure HIV infection and can have severe side effects. Most patients will also develop resistance to these drugs.
About KP-1461
KP-1461 is an oral, anti-viral drug that has been shown to be effective in ablating HIV infection and well tolerated in preclinical studies. The Phase 1b trial of KP-1461 follows the successful completion of a Phase 1a trial that accrued 42 healthy subjects and demonstrated KP-1461 to be well-tolerated, with no dose-related toxicities. KP-1461 utilizes a new therapeutic approach called “Selective Viral Mutagenesis(TM),” which works to eliminate a targeted virus by increasing the natural viral rate of mutation. KP-1461 may provide reduced toxicities and a treatment option for HIV patients who have failed, or become resistant, to other conventional therapeutics.
About Koronis
Koronis Pharmaceuticals, Inc. is a privately held biotechnology company dedicated to the development of novel anti-viral therapeutics. In addition to the Company’s lead product candidate, KP-1461 for AIDS/HIV, the company has products in development for the treatment of hepatitis C infection. For more information on Koronis, please visit www.koronispharma.com.
Media Contact: Julie Rathbun Julie_rathbun@msn.com 206-769-9219
Koronis Pharmaceuticals, Inc.
CONTACT: Julie Rathbun, +1-206-769-9219, or Julie_rathbun@msn.com, forKoronis Pharmaceuticals, Inc.
Web site: http://www.koronispharma.com/
