Rezolute Completes Enrollment of its Phase 2 Study in Diabetic Macular Edema (“DME”)

Plans to report topline data mid-second quarter 2024

Excerpt from the Press Release:

REDWOOD CITY, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the completion of enrollment in its RZ402 Phase 2 study in diabetic macular edema (“DME”). RZ402 is a selective and potent plasma kallikrein inhibitor (“PKI”) 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 naïve 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.

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