Rezolute Inc (NASDAQ: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.
- Price Action: RZLT shares are down 2.09% at $4.21 during the market session on the last check Tuesday.
