Business
Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress
Planning to initiate Phase 3 Study for RZ358 (“sunRIZE study”) in the fourth quarter of 2023 REDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) --
About this update from Rezolute, Inc.
[{"type":"text","content":"Planning to initiate Phase 3 Study for RZ358 (“sunRIZE study”) in the fourth quarter of 2023\nREDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt treatment paradigms for devastating metabolic diseases, today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2023. “We are delighted that we are poised to initiate sunRIZE – our Phase 3 study of RZ358, which we hope will bring us one step closer to making this therapy available to patients and their families suffering from congenital hyperinsulinism. We are also anticipating results from our Phase 2 study of RZ402 in the first quarter of 2024, where we hope to demonstrate the safety and proof-of-concept of our oral therapy for diabetic macular edema,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “As we look ahead to these upcoming milestones, we remain committed to our mission of delivering transformative therapies to patients with devastating metabolic diseases.” Corporate and Clinical Highlights RZ358, monoclonal antibody for the treatment of congenital hyperinsulinism (HI) Following the successful Phase 2b RIZE study of RZ358 in congenital HI, which demonstrated that RZ358 safely and substantially improved hypoglycemia, the Company plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023. Topline results from the sunRIZE study are expected in the first half of 2025. RZ402, oral plasma kallikrein inhibitor to treat diabetic macular edema (DME) In December 2022, Rezolute announced the initiation of a Phase 2 study of RZ402 in patients with DME. This is a 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 in participants with DME who are naïve to or have received limited anti-VEGF injections. Study enrollment is ongoing, and the Company anticipates topline results from this study in the first quarter of 2024. Fourth Quarter and Full Year Fiscal 2023 Financial Results Cash and cash equivalents totaled $16.0 million and investments in mark...