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Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema

RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye

Excerpt from the Press Release:

REDWOOD CITY, Calif., Dec. 15, 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 that the Company has initiated a Phase 2 proof-of-concept study for RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of Diabetic Macular Edema (DME). The current standard of care for DME is anti-vascular growth factor (anti-VEGF) injections into the eye, requiring repeated administration over recurring periods of time to preserve vision, with significant treatment burden and occasional serious side effects. The invasive route of administration, coupled with inadequate responsiveness in some patients, leads to overall undertreatment and suboptimal vision outcomes in DME patients.

“The initiation of this Phase 2 study is an important milestone in our mission to address the serious unmet need in the current DME treatment paradigm,” said Raj Agrawal, M.D., Vice President, and Head of Ophthalmological Clinical Development at Rezolute. “By targeting an alternative pathway and route of administration to the current standard of care, we believe that orally-administered RZ402 has the potential to be a less burdensome and more beneficial treatment option for all patients suffering with DME, including the approximately 50% of patients that don’t adequately respond to anti-VEGFs.”

“We believe that RZ402 represents the potential for a significant change in the treatment paradigm of DME,” said Brian Roberts, M.D., Chief Medical Officer at Rezolute. “By targeting this microvascular diabetes complication with an oral-systemic PKI, analogous to the management of other diabetes complications, RZ402 has the potential to improve overall clinical outcomes by driving earlier treatment intervention and preventing disease progression and vision loss for patients with DME. We look forward to building upon the positive data generated in our Phase 1b trial and remain excited by the broad clinical potential of RZ402 to more effectively treat diseases associated with excessive kallikrein-kinin activity.”

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