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Handok’s Affiliate Rezolute Confirms Efficacy and Safety in Phase 2 Clinical Trials of Diabetic Macular Edema Treatment RZ402
- 2024.05.22
- 600
Handok’s Affiliate Rezolute Confirms Efficacy and Safety in Phase 2 Clinical Trials of Diabetic Macular Edema Treatment RZ402
Handok's American biotech affiliate Rezolute, Inc. announced positive topline results on May 21 (US time) from the Phase 2 clinical trial of RZ402 targeting patients with diabetic macular edema (DME).
The study was conducted on DME patients who had no or limited treatment with anti-vascular endothelial growth factor (anti-VEGF) injections. It was a randomized, double-blind, placebo-controlled, parallel-group clinical trial involving 94 patients across multiple institutions in the US, assessing the safety, efficacy, and pharmacokinetics of RZ402 as a monotherapy over 12 weeks. Participants were randomly assigned to one of three doses of RZ402 (50, 200, 400 mg) or a placebo control group and took the study drug once daily for 12 weeks, followed by a 4-week follow-up observation.
The results showed that RZ402 achieved the primary research objectives, confirming a decrease in CST and an excellent safety profile. All dosage levels of RZ402 showed a significant improvement in CST compared to placebo (up to approximately 50 microns; p=0.02), with a consistent decrease during the treatment period and continuing at the end of treatment. Although there was no significant difference between RZ402 dosage levels, the 200 mg dose showed the strongest response. Sub-analysis based on DME severity (CST ≥400 microns) revealed an improvement of about 75 microns in CST at the 200 mg dose.
Secondary and exploratory endpoint analyses indicated that the clinically observed reduction in CST could predict long-term visual acuity improvements. 20% of participants (5 individuals) treated with the 200 mg dose of RZ402 showed a one-step improvement in the diabetic retinopathy severity score (DRSS). Safety analysis, including side effects, showed no notable adverse reactions compared to placebo.
The study was conducted on DME patients who had no or limited treatment with anti-vascular endothelial growth factor (anti-VEGF) injections. It was a randomized, double-blind, placebo-controlled, parallel-group clinical trial involving 94 patients across multiple institutions in the US, assessing the safety, efficacy, and pharmacokinetics of RZ402 as a monotherapy over 12 weeks. Participants were randomly assigned to one of three doses of RZ402 (50, 200, 400 mg) or a placebo control group and took the study drug once daily for 12 weeks, followed by a 4-week follow-up observation.
The results showed that RZ402 achieved the primary research objectives, confirming a decrease in CST and an excellent safety profile. All dosage levels of RZ402 showed a significant improvement in CST compared to placebo (up to approximately 50 microns; p=0.02), with a consistent decrease during the treatment period and continuing at the end of treatment. Although there was no significant difference between RZ402 dosage levels, the 200 mg dose showed the strongest response. Sub-analysis based on DME severity (CST ≥400 microns) revealed an improvement of about 75 microns in CST at the 200 mg dose.
Secondary and exploratory endpoint analyses indicated that the clinically observed reduction in CST could predict long-term visual acuity improvements. 20% of participants (5 individuals) treated with the 200 mg dose of RZ402 showed a one-step improvement in the diabetic retinopathy severity score (DRSS). Safety analysis, including side effects, showed no notable adverse reactions compared to placebo.
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