Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?
Tuesday, Rezolute Inc (NASDAQ:RZLT) released topline results from the Phase 2 study of RZ402 in diabetic macular edema patients who are naïve to or have received limited anti-vascular growth factor (anti-VEGF) injections.
94 participants were enrolled to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week (three-month) treatment period.
RZ402 met both primary endpoints of change in macular edema (central subfield thickness or CST) and a good safety profile.
CST improved significantly at all RZ402 dose levels compared to placebo (up to approximately 50 microns; p=0.02)
Continued downward trajectory in CST over course of study and at the end of treatment.
No significant difference between RZ402 dose levels, though the response was largest at the 200 mg dose.
A sub-analysis by DME severity (CST ≥400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose.
CST declined in most patients who received the 200 mg dose of RZ402, including clinically significant improvements from baseline in more than 20% of participants, compared to none in placebo, with high rates of worsening.
RZ402 was safe and well-tolerated. Adverse events (AEs) were generally mild, and rates were comparable to placebo.
No ocular adverse effects that are typically seen with intravitreal injections were observed.
Target concentrations were exceeded at all three doses and continued supporting once-daily oral dosing.
No significant improvements in Best Corrected Visual Acuity (BCVA) compared to placebo.
In line with expectations for a study of this duration
Observed improvements in CST would predict visual improvements in a longer-duration study.
Five RZ402-treated participants at 200 mg (20%) experienced a one-step improvement in the Diabetic Retinopathy Severity Score (DRSS) compared to one participant in placebo.
Price Action: At the last check on Wednesday, RZLT shares were up 31.3% at $3.94 during the premarket session.
"ACTIVE INVESTORS' SECRET WEAPON" Supercharge Your Stock Market Game with the #1 "news & everything else" trading tool: Benzinga Pro - Click here to start Your 14-Day Trial Now!
Get the latest stock analysis from Benzinga?
This article Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday? originally appeared on Benzinga.com
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
