Rezolute announces RZ402 trial meets both primary endpoints

Rezolute announced topline results from the Phase 2 clinical study of RZ402 in patients with DME who are naive to or have received limited anti-vascular growth factor, or anti-VEGF, injections. 94 participants were enrolled in the U.S. multi-center, randomized, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period. RZ402 met both primary endpoints of change in macular edema, or CST, and a good safety profile. CST improved significantly at all RZ402 dose levels compared to placebo. Continued downward trajectory in CST over course of study and at end of treatment. No significant difference between RZ402 dose levels, though response was largest at the 200 mg dose. Sub-analysis by DME severity indicates an improvement of approximately 75 microns at the 200 mg dose. CST declined in most patients who received the 200 mg dose of RZ402, including clinically significant improvements from baseline in more than 20% of participants, compared to none in placebo, with high rates of worsening. RZ402 was safe and well-tolerated. Adverse events, or AEs, were generally mild and rates were comparable to placebo. Three participants experienced serious AEs which were all judged by the Investigator as unrelated to study drug. No ocular adverse effects that are typically seen with intravitreal injections. Electrocardiograms, or ECGs, vitals, and safety labs were unremarkable. Target concentrations were exceeded at all three dose levels and continue to support once daily oral dosing. In terms of secondary endpoints, no significant improvements in BCVA compared to placebo . In-line with expectations for a study of this duration. Observed improvements in CST would predict visual improvements in a longer duration study. Five RZ402 treated participants at 200 mg experienced a 1-step improvement in Diabetic Retinopathy Severity Score compared to one participant in placebo. The Company plans to present these data and further findings at an upcoming medical conference.