Rezolute initiates Phase 3 study of RZ358

Rezolute announced the initiation of sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism. Following country-level regulatory and ethics committee approvals, the first clinical site has now been activated outside the US, allowing for patient screening and enrollment to commence. Additional sites are being activated on a regular basis over the coming weeks and into the beginning of 2024. “The start of the Phase 3 study marks a significant milestone in the development of RZ358 and exemplifies the tremendous progress of our Company as a whole. The unmet medical need for patients and their families living with cHI is unequivocal, particularly given that the only approved therapy, diazoxide, is unable to work in more than half of patients, or alternatively is associated with significant side effects in those that respond,” remarked Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “Better therapies are desperately needed, and we look forward to working closely with sites throughout the world to advance patient screening and enrollment in this pivotal study, so as to move one step closer to realizing that goal.”