
News: Advancing Innovative HIV Treatment with KP-1461 Development
Koronis Pharmaceuticals is making significant progress with KP-1461, an innovative approach to treating HIV using nucleoside analog technology
KP-1461 Clinical Development Timeline

2004
Koronis submitted an Investigational application to the FDA in August to begin clinical trials for KP-1461. Preclinical studies showed that the active form, KP-1212, could introduce mutations in the HIV virus, potentially limiting its ability to replicate. The FDA approved the IND in November, and Phase 1a trials began to assess safety and pharmacokinetics in healthy volunteers.

2005
By March, Phase 1a trials were completed successfully, showing no significant side effects, and the results aligned with preclinical studies. In May, Koronis amended the IND to begin Phase 1b trials, involving a 14-day multi-dose regimen for HIV-positive patients to assess safety, tolerability, and antiviral activity..

2006
Koronis presented its advancements at the BIO CEO & Investor Conference in February, discussing the progress of their approach to HIV solution. In March, the company participated in the Invest Northwest® investor-CEO forum, highlighting the ongoing development of KP-1461.
KP-1461 is a prodrug that is converted into its active form, KP-1212, in the body. This form integrates into the HIV virus’s genetic material during replication, causing mutations that disrupt the virus’s ability to reproduce. Over time, this leads to the production of defective viral particles, reducing the virus's ability to spread.

Exploring the Future of KP-1461 in HIV Solutions
Koronis continues to investigate the potential of KP-1461, particularly for individuals with HIV and resistant strains. Early data suggests it is well tolerated, and ongoing clinical studies aim to further evaluate its effectiveness and unique mechanism.