Koronis Pharmaceuticals Begins Phase 2a Proof of Concept Study of KP-1461, a Novel, Viral Decay Acceleration Agent for HIV Infection
- Category: Small Molecules
- Published on Wednesday, 27 June 2007 04:00
- Hits: 1219
SEATTLE, WA, USA | June 26, 2007 | Koronis Pharmaceuticals, Inc. announced today that patient enrollment has begun in a Phase 2a study of KP-1461, a novel oral small-molecule therapeutic that works through Viral Decay Acceleration(TM) (VDA) for the treatment of human immunodeficiency virus (HIV) infection.
"KP-1461 is an investigational compound that is a truly different approach to the treatment of HIV," said Robert Schooley, M.D., Head, Division of Infectious Diseases at the University of California, San Diego, School of Medicine and the Lead Principal Investigator for the trial. "The preclinical data for KP-1461 demonstrates that HIV can be extinguished. Whether this same effect will be seen in humans is the subject of this clinical trial. While currently approved HIV treatments are designed to inhibit the growth of HIV, KP-1461 induces mutations within the HIV genome leading to degraded viral fitness and viral collapse. Should this clinical trial show the same effect as noted in cell culture experiments, this will represent an entirely new and welcomed approach to HIV therapeutics."
"While KP-1461 has demonstrated the potential to ablate HIV infection in vitro and was generally safe and well tolerated in Phase 1 trials, this Phase 2a trial will provide the first opportunity to evaluate the efficacy of the VDA approach in HIV infected patients," said Stephen Becker, M.D., Chief Medical Officer of Koronis. "We eagerly await the results of this trial and the potential future development opportunities of the drug."
Phase 2a Trial Design
The Phase 2a study (KP-1461-201) is an open label trial that will evaluate the safety, efficacy and tolerability when KP-1461 is administered as monotherapy in treatment-experienced patients. The study will enroll up to 32 individuals who harbor significant resistance to conventional antiretroviral therapies. Patients will receive 1600 mg of KP-1461 twice daily for 124 days. The study will be conducted at 24 academic and community-based clinical research centers in the United States. An independent Data Safety Monitoring Board will provide safety oversight.
About Viral Decay Acceleration TM
VDA is a novel therapeutic mechanism with application against HIV and other viral infections. VDA increases the virus' naturally high mutation rate, causing an accumulation of mutations within the viral genome. This leads to impaired viral function and collapse of the viral population. Unlike conventional antiretroviral agents, KP-1461's action does not directly inhibit viral enzymes, a feature which may significantly limit the virus' ability to develop resistance against the drug.
Koronis Pharmaceuticals, Inc. is a privately held biotechnology company developing anti-viral therapeutics based on Viral Decay Acceleration(TM). In addition to the Company's lead product candidate, KP-1461 for AIDS/HIV, the Company has programs directed toward the development of therapeutics for hepatitis C and RSV. For more information on Koronis, please visit http://www.koronispharma.com.
SOURCE: Koronis Pharmaceuticals, Inc.