Biopharmaceutical company Rezolute has initiated a Phase II proof-of-concept study for RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of diabetic macular oedema (DMO).
The current standard of care for DMO 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 DMO patients.
Raj Agrawal, Vice President, and Head of Ophthalmological Clinical Development at Rezolute, said: “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 DMO, including the approximately 50% of patients that don’t adequately respond to anti-VEGFs.”
The Phase II study is a multicentre, randomised, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 as monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections.
Brian Roberts, Chief Medical Officer at Rezolute, added: “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 DMO.”