Tuesday, February 22, 2022

Rezolute Highlights Early-Stage Study Results For RZ402 In Diabetic Macular Edema

 Rezolute Inc 

 (Get Free Alerts for RZLT) announced topline data from its Phase 1b multiple-ascending dose (MAD) study of RZ402, a plasma kallikrein inhibitor (PKI) for diabetic macular edema (DME). 

  • Results of the MAD study further validate and support the potential for once-daily oral dosing and enable the Company to initiate a Phase 2 proof-of-concept study later this year.
  • The recently completed MAD study showed dose-dependent increases in systemic exposures, with repeat-dosing to steady-state resulting in the highest concentrations of RZ402 explored to date, exceeding 200 ng/mL and 50 ng/mL at peak and 24-hour trough, respectively. 
  • The MAD study results showed that RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the SAD study. There were no serious adverse events, adverse drug reactions, or identified risks.
  • Rezolute plans to present full study results at a medical conference this year.

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