Rezolute’s oral option for retinal disease finds Phase II success
22 May 2024
Clinical ResultPhase 2
RezoluteRezolute said its experimental treatment for diabetic macular edema (DME) met both primary endpoints in a Phase II study, suggesting oral RZ402 could offer a more easily-administered alternative to standard anti-VEGF injections, which are dosed intravitreally.
The topline results, shared late on Tuesday, boosted the company's shares up 50% during after-hours trading, although the firm closed down about 6% on Wednesday.
Retinal thickness reduction
The study recruited 94 patients with DME who are naïve to or have had limited anti-VEGF injections to receive a 50mg, 200mg, or 400mg daily dose of RZ402, or placebo, for 12 weeks. The oral small molecule is a selective plasma kallikrein inhibitorplasma kallikrein inhibitor.
On the primary efficacy endpoint, all dose levels of RZ402 significantly reduced central subfield thickness (CST) compared with placebo, with a magnitude of improvement of about 50 microns. Rezolute noted that there was no significant difference between dose levels, although patient response was largest at the 200mg dose.
JMP Securities analysts said the results suggest the candidate met “a clinically meaningful threshold,” adding that a lack of treatment plateau at the end of the study supports “the potential for further benefit with longer duration therapy.”
Quan Dong Nguyen, a member of Rezolute’s Scientific Advisory Board, said the reductions in CST were impressive, as “retinal thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients,” adding that the data “are supportive of the potential for a new first-line, non-invasive treatment for DME.” Nguyen also is a professor of ophthalmology at the Byers Eye Institute and a professor of medicine and paediatrics at the Stanford University School of Medicine.
Rezolute said that the oral treatment was safe and well-tolerated, with generally mild adverse events (AEs) that were comparable in severity and number to those seen in the placebo arm. There were no ocular AEs that can occur with intravitreal injections.
However, RZ402 missed the secondary endpoint of improving Best Corrected Visual Acuity (BCVA) versus placebo, although the analysts noted that that result was not unexpected, given the short duration of the study.
According to the JMP analysts, Rezolute plans to find a partner to advance the programme into late-stage development, which the firm believes “can maximise potential broad opportunities in and beyond DME.
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