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KP-1461

KP-1461 Summary
Koronis has completed Phase 1a, 1b and 2a clinical studies demonstrating KP-1461 to be generally safe and well tolerated and having drug activity. The Company has completed in vitro, serial passage studies that confirm viral ablation and support the mechanism of action of Viral Decay Acceleration, consistent with original preclinical results. The Company is currently in the process of refining the KP-1461 oral drug formulation and preparing for the next clinical trials.

Phase 2a Trial
An Open-label, Multicenter, Mechanism Validation Study to Evaluate the Safety, Efficacy, and Tolerability of KP-1461 as Monotherapy for 124 Days in ARV-experienced, HIV-1-infected Subjects. This study enrolled 27 of the 32 subjects targeted for the trial. Koronis stopped this trial prior to complete enrollment in order to conduct in vitro serial passage studies, which have confirmed HIV ablation consistent with original preclinical results. The trial closure was not requested or required by the FDA and was not related to any safety concerns or adverse events during the trial. KP-1461 was shown to be well tolerated. Results also demonstrated drug activity as subjects treated with KP-1461 had an increased frequency of HIV mutations that were statistically significant as compared to a separate control group.

Phase 1b Trial
03-24A Double-Blind, Placebo-Controlled, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of KP-1461 in HIV+ Adults Who Have Failed Two or More Highly Active Antiretroviral Regimens (HAART). The study demonstrated that KP-1461 was well tolerated over 2 weeks of dosing. The study also showed that the highest dose level (3200 mg twice per day) was associated with a viral load decrease of 0.4 log that was statistically significant when compared to placebo.

Phase 1a Trial
A Double-Blind, Placebo-Controlled Dose Escalation Study of the Safety Tolerability, and Pharmacokinetics of a Single Oral Dose of KP-1461 in Normal Healthy Adults. The study demonstrated that a single dose of KP-1461 was well tolerated and had acceptable pharmacokinetics.

Patients or physicians who would like more information about clinical trials should contact Koronis koronis@koronispharma.com