Business
Rezolute Reports First Quarter Fiscal 2023 Results and Highlights Company Progress
Phase 2 proof-of-concept study of RZ402 expected to be initiated by the end of this year REDWOOD CITY, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Rezolute,
About this update from Rezolute, Inc.
[{"type":"text","content":"Phase 2 proof-of-concept study of RZ402 expected to be initiated by the end of this year REDWOOD CITY, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the first quarter of fiscal 2023 ended September 30, 2022. “I am extremely pleased with our progress this year, having reported positive data from both our clinical programs, Phase 1b study of RZ402 for Diabetic Macular Edema and Phase 2b study of RZ358 for Congenital Hyperinsulinism (HI), as well as completing a $130 million financing to advance both the molecules into the next phase of clinical studies,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “We are on track to initiate a Phase 2 proof-of-concept study for RZ402 by the end of this year, and we are aligning with regulatory authorities in the U.S. and in Europe on next steps in our Phase 3 clinical program for RZ358.” Corporate and Clinical Highlights RZ358, monoclonal antibody for the treatment of congenital hyperinsulinism The results of the Phase 2b RIZE study of RZ358 in patients with congenital HI were presented at the 2022 Pediatric Endocrine Society Annual Meeting as well as at the 60th European Society for Paediatric Endocrinology (ESPE). RZ358 demonstrated good safety and tolerability across all doses with no study discontinuations or adverse drug reactions. Results exceeded expectations for correction of hypoglycemia, including a highly significant reduction of ~75% in hypoglycemia events by blood glucometer (BGM) as well as time in hypoglycemia by continuous glucose monitoring (CGM) at anticipated therapeutics doses. RZ402, oral plasma kallikrein inhibitor to treat diabetic macular edema (DME) Rezolute presented clinical data from its Phase 1b multiple-ascending dose (MAD) study of RZ402 in Diabetic Macular Edema (DME) in a podium presentation at The Retina Society 55th Annual Scientific Meeting. The data further validated and supported the potential for once daily oral dosing and enables Rezolute to initiate a Phase 2 proof-of-concept study by the end of the year. First Quarter Fiscal 2023 Financial Results Cash and cash equivalents totaled $...