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
“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
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. Anti-vascular growth factor (anti-VEGF) injections into the eye are the current standard of care for DME, but require frequent treatment over long periods of time to preserve vision. Due to their invasive route of administration and occasional serious side effects, there is a tendency to delay treatment until later in the disease course, and long-term compliance with eye injection regimens can be difficult for patients. Coupled with inadequate responsiveness in a significant percentage of patients, this leads to overall undertreatment and suboptimal vision outcomes in DME patients.
About RZ402 and the contact activation kallikrein-kinin system
The contact-activation kallikrein-kinin system promotes increased vascular permeability and inflammation via key downstream mediators, including bradykinin, and activation of the intrinsic pathway of coagulation. Pathophysiologic upregulation of this system has been linked to a variety of diseases which are characterized by vascular dysfunction, including diabetic macular edema.
RZ402 is a selective and potent plasma kallikrein inhibitor being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME). By inhibiting the formation of kallikrein, RZ402 is designed to block downstream bradykinin production and the pro-inflammatory, pro-coagulant, and fluid-leakage contact-activation cascade.
About RZ402-101
RZ402-101 is a first-in-human Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study in healthy adult volunteers. The objectives of the study are to characterize the safety profile (including maximum tolerated dose) and pharmacokinetics of RZ402 administered as single oral doses in sequential ascending dose fashion. The study will be conducted in a minimum of 30 subjects in at least three planned sequential dose-level cohorts comprising ten subjects per cohort. Within each dose cohort, subjects will be randomized in an 8:2 ratio to receive either RZ402 oral solution or matched placebo. After receiving single blinded doses, participants will remain in-clinic for seven days for serial pharmacokinetic and safety assessments, before completing two outpatient follow-up visits at study days 14 and 30. Dose advancement will proceed in staggered fashion every two weeks as appropriate, following blinded reviews of data from the preceding cohort(s). The study is expected to conclude in the first half of 2021.
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