Rezolute completes enrollment of RZ401 Phase 2 study in DME

Rezolute announced the completion of enrollment in its RZ402 Phase 2 study in diabetic macular edema. RZ402 is a selective and potent plasma kallikrein inhibitor being developed as a potential oral therapy for the chronic treatment of DME. The study is a multi-center, randomized, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a once daily oral monotherapy over a 12-week treatment period and four-week follow-up in participants with DME who are naive to, or have received limited anti-VEGF injections. Eligible participants were randomized equally to either a placebo control arm or one of three RZ402 active treatment arms at doses of 50, 200, and 400 mg. This proof-of-concept study was designed to enroll up to 100 participants to evaluate activity and safety by individual dose level and in pooled fashion. In the fourth quarter 2023, based on considerable momentum, the Company elected to keep enrollment open into December to include as many eligible patients as possible. Screening is now complete, and final study enrollment is expected to be approximately 95 participants. Additionally, although each participant has an assigned study eye, it is expected that a meaningful number of non-study eyes will be eligible for evaluation. Since DME results from a systemic vascular complication associated with diabetes, it commonly affects both eyes. RZ402, as an orally available systemic therapy, has the potential to treat both eyes simultaneously. As a result of the extension of the enrollment period, the Company now plans to report topline results in the middle of the second quarter 2024, rather than the end of the first quarter 2024.