Benzinga | Aug 10, 2021 07:12AM EDT

Rezolute Announces Initiation of Multiple-Ascending Dose Study of RZ402, Rezolute's Oral PKI for Treatment of DME

Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced that the Company has initiated dosing in a Phase 1b multiple-ascending dose study of RZ402, Rezolute's investigational oral plasma kallikrein inhibitor (PKI) for the treatment of diabetic macular edema (DME). Rezolute also announced the appointment of ophthalmology expert and key opinion leader, Dr. Rajat Agrawal, MD, MS, as Vice President, Clinical Development to lead the RZ402 clinical development program.

"The Phase 1b study will evaluate the safety of RZ402 in healthy volunteers and inform the dose range selection in the phase 2 proof-of-concept study, planned for next year," said Brian Roberts, MD, Senior Vice President and Head of Clinical Development at Rezolute. "There is a significant unmet need for new ways to treat DME, due to the high treatment burden of current standard of care involving anti-VEGF injections into the eye. With Dr. Agrawal's expertise as a retinal specialist and his drug development expertise in the therapeutic area, we're looking forward to developing a more convenient oral therapy with the potential to prevent and treat the vision loss commonly experienced by patients with diabetes."

Dr. Agrawal brings over three decades of experience across both the clinical and commercial spectrums, having practiced as an ophthalmology and retina specialist for more than 25 years, and having served as an executive at other clinical-stage biotechnology companies. Dr. Agrawal also founded Retina Global, an international nonprofit focused on sustainable solutions to retinal disease management globally, aimed at evaluating patients, providing medical and surgical treatment and training local ophthalmologists.

"It is a privilege to have the opportunity to work on a program with the potential to have such a profound and positive impact on patients' lives," said Dr. Agrawal. "I regularly witness the unfortunate impact of retinal diseases on patients, and Rezolute's innovative approach would be a huge step forward for the DME community. I am honored to be joining this team, and I look forward applying my expertise to the further advancement of the RZ402 program."