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Saturday, 03/02/2024 4:38:40 PM

Saturday, March 02, 2024 4:38:40 PM

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P2 DME trial is fully enrolled with primary completion in April ..results probably in late May
https://www.clinicaltrials.gov/study/NCT05712720?tab=history&a=7

About RZ402
RZ402 is a selective and potent PKI being developed as a potential once-daily oral therapy for the chronic treatment of DME. By inhibiting the activation of kallikrein, RZ402 is designed to block bradykinin production and its resulting effects on vascular leakage and inflammation.

RZ402 has been shown to reduce and prevent retinal vascular leakage in animal models by up to 90%. Results from a Phase 1b multiple ascending dose (MAD) study showed that RZ402 was readily bioavailable with dose-dependent increases in systemic exposures.
RZ402 concentrations substantially exceeded target efficacious concentrations based on a combination of in-vitro and in-vivo pharmacology studies in animals, supporting the potential as a once daily therapy for DME.
RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the single ascending dose (SAD) study.
There were no serious adverse events, adverse drug reactions, or identified risks.

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