As soon as favorable topline results from a clinical study was released, the stock price of Rezolute, Inc. (NASDAQ: RZLT) shot up on US stock charts. RZLT shares gained 46.33% to $4.39 in after-hours trading. That followed a 6.76% in the stock price to close the regular session at $3.00.
Clinical Study Insights
Rezolute (RZLT) presented promising findings from the RZ402 Phase 2 study, which managed DME patients treated with injections of anti-vascular endothelial growth factor (anti-VEGF) either seldom or not at all.
The research’s results, which demonstrate a significant decrease in central subfield thickness (CST) in all three dosing groups, are highly noteworthy for the DME community. For DME patients, CST is an essential biomarker for evaluating the possible advantages of a treatment. The promise of RZ402 as a new, non-invasive first-line therapy for DME is supported by these data.
Study Design And Results
The U.S.-based multi-center, randomized, double-masked, placebo-controlled, parallel-arm study enrolled 94 participants. This research was out to assess the pharmacokinetics, safety, and effectiveness of RZ402 when used as a monotherapy for the duration of the 12-week treatment regimen.
Following a four-week follow-up period, participants were randomized to receive one of three doses of RZ402 including 50 mg, 200 mg, or 400 mg; or a placebo, provided once daily. It was anticipated that there would be no appreciable increases in best-corrected visual acuity (BCVA) over placebo given the length of the research.
However, improvements in CST were observed, indicating potential for visual improvements in longer-term studies. Additionally, five participants treated with RZ402 exhibited a one-step improvement in the Diabetic Retinopathy Severity Score (DRSS) compared to one participant in the placebo group.
Future Directions
Rezolute plans to present these encouraging data and additional findings at an upcoming medical conference. The potential for an oral therapy to treat DME is particularly exciting, as it could enable earlier intervention and treatment of both eyes, possibly altering the long-term prognosis for DME patients.
