Rezolute Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME)

Met primary study endpoints: good safety profile and reduction in central subfield thickness (CST)

First oral therapy to demonstrate reduction in macular edema; supports potential for early disease intervention

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REDWOOD CITY, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced positive topline results from the Phase 2 clinical study of RZ402 in patients with DME who are naïve to or have received limited anti-vascular growth factor (anti-VEGF) injections.

“The results are monumental for the DME community,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Professor of Pediatrics at the Stanford University School of Medicine, and a member of Rezolute’s Scientific Advisory Board. “I am impressed by the significant reduction in CST in this study across all three dosages as retinal thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients. These data are very encouraging and are supportive of the potential for a new first-line, non-invasive treatment for DME.”

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 (three month) treatment period.

“I am encouraged to see the initial results of this proof-of-concept study and am enthusiastic about the possibility of an oral therapy to treat DME,” said Arshad Khanani, MD, MA, FASRS, Clinical Professor at the Reno School of Medicine, University of Nevada, and Primary Investigator of the study. “Importantly, an oral therapy would afford us the opportunity to address both eyes and intervene much earlier, potentially altering the long-term prognosis for individuals with DME.”

“We are very excited about these results and, importantly, would like to thank the patients, the leading retina specialists across the country, and their motivated staff who all made this study possible,” said Raj Agrawal, MD, Vice President and Head of Ophthalmological Clinical Development at Rezolute.

Study design and eligibility criteria

• DME patients with mild to moderate non-proliferative diabetic retinopathy (DR)
• Patients must have received no more than three anti-VEGF injections previously (none within eight weeks of randomization)
• CST of ≥320 microns in males and ≥305 microns in females
• Best Corrected Visual Acuity (BCVA) of ≤78 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) assessment
• Eligible participants were randomized equally, to one of three RZ402 active treatment arms at doses of 50, 200, and 400 mg, or a placebo control arm, to receive study drug once daily for 12 weeks, before completing a four-week follow-up