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Rezolute Announces Initiation of Phase 1 Study of RZ402, an Oral Plasma Kallikrein Inhibitor for the Treatment of Diabetic Macular Edema
RZ402 is a plasma kallikrein inhibitor being investigated as a potential once-daily, oral therapy for DME Trial initiation marks expansion of the Company’s
About this update from Rezolute, Inc.
[{"type":"text","content":"RZ402 is a plasma kallikrein inhibitor being investigated as a potential once-daily, oral therapy for DME Trial initiation marks expansion of the Company’s pipeline to a second clinical-stage program, reinforcing its commitment to advancing novel therapies for patients with serious unmet metabolic diseases REDWOOD CITY, Calif., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), today announced the initiation of dosing in a Phase 1 first-in-human clinical study of RZ402, an investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME). The study (RZ402-101) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of RZ402 in healthy adult volunteers. The Company expects to complete the study in the first half of 2021. “With the initiation of our clinical trial with RZ402 we now have a second program in clinical development, further highlighting our commitment to build a broad pipeline of novel and targeted therapies with the potential to change the lives of patients suffering from serious metabolic diseases,” said Brian Roberts, M.D., senior vice president and head of clinical development at Rezolute. Dr. Roberts continued, “Plasma kallikrein is a validated therapeutic target in hereditary angioedema, and we believe it has important potential therapeutic implications in other conditions characterized by vascular leakage, such as occurs at the retinal microvasculature in DME. Clinical trials investigating intravitreal injections of PKIs in DME have highlighted the potential of this therapeutic target, and we are uniquely positioned to favorably shift the clinical development and treatment paradigm in DME with RZ402’s novel oral dosing. Oral-systemic administration of RZ402 may optimize kallikrein inhibitor levels at the retinal microvasculature, while providing patients with the comfort and convenience of a once-daily, oral treatment.” About Diabetic Macular Edema (DME) Diabetic retinopathy (DR) affects approximately one third of adults with diabetes and can lead to loss of vision. DME is a severe vision-threatening complication of DR characterized by swelling of the retina and thickening of the macula, the part of the eye that is responsible for sharp, straight ahead vision. Ant...