Why Is Small-Cap Metabolic-Focused Rezolute Stock Trading Higher On Wednesday?

Tuesday, Rezolute Inc 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.