Kiora Reports No Serious Adverse Events in Phase 1 KIO-301 Study, Initiates Phase 2 Trial
Kiora published peer-reviewed findings from its Phase 1 ABACUS-1 study of KIO-301 in retinitis pigmentosa, showing no serious adverse events or dose-limiting toxicities across six participants over 30 days. The company has launched the randomized Phase 2 ABACUS-2 trial evaluating higher doses for functional vision improvements.
1. Phase 1 Results Published
Kiora published peer-reviewed findings from its open-label, dose-escalation Phase 1 ABACUS-1 trial of KIO-301 in advanced retinitis pigmentosa, involving six participants (12 eyes) over 30 days with intravitreal dosing and functional vision assessments.
2. Safety and Feasibility Outcomes
The trial met its primary endpoint with no serious adverse events, dose-limiting toxicities, or drug-related intraocular inflammation; observed ocular adverse events were mild, transient and consistent with known effects of intravitreal injections.
3. Phase 2 ABACUS-2 Trial Initiation
Based on positive safety and feasibility data, Kiora launched a randomized, controlled Phase 2 ABACUS-2 trial to test higher doses of KIO-301, include a control arm, and measure functional visual improvements with an open-label extension.
4. KIO-301 Mechanism and Development
KIO-301 is a small-molecule photoswitch designed to enter retinal ganglion cells and render voltage-gated ion channels light-responsive via an azobenzene moiety, offering potential applicability across multiple inherited and age-related retinal degenerations.