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Clinical Trials


KP-1461

Koronis Pharmaceuticals is currently conducting clinical trials for KP-1461, a novel therapeutic agent being evaluated for HIV treatment. The following outlines the details of the ongoing studies:​

1

Phase 2a Trial: Ongoing

This is an open-label, multicenter study designed to validate the mechanism of KP-1461 as monotherapy. The trial focuses on assessing the safety, efficacy, and tolerability of KP-1461 over a 124-day treatment period in HIV-1-infected individuals who have prior experience with antiretroviral therapy (ARV). The goal of this phase is to better understand how KP-1461 performs in a real-world context for individuals with a history of ARV use.

2

Phase 1b Trial: Ongoing

This phase involves a double-blind, placebo-controlled, dose-escalation study. Its purpose is to investigate the safety, tolerability, and pharmacokinetics of multiple oral doses of KP-1461 in HIV-positive adults who have not responded to two or more highly active antiretroviral therapy (HAART) regimens. This trial is particularly important for evaluating the potential of KP-1461 to serve as a viable option for individuals with limited treatment options.

3

Phase 1a Trial: Completed

This trial involved a double-blind, placebo-controlled, dose-escalation study in which the safety, tolerability, and pharmacokinetics of a single oral dose of KP-1461 were assessed in healthy adult volunteers. This phase established initial safety data and pharmacokinetic properties before advancing to trials involving HIV-positive individuals.