Ocuphire Pharma Starts Mid-Stage APX3330 Study In Diabetic Retinopathy Patients

Ocuphire Pharma Inc OCUP has screened the first patient in Phase 2 ZETA-1 trial evaluating APX3330 in non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (mild PDR).
Effects on diabetic macular edema will be explored as a secondary outcome.
APX3330 is a small molecule oral drug candidate and a first-in-class inhibitor of the transcription factor regulator Ref-1 (reduction-oxidation effector factor-1).
APX3330 blocks the downstream pathways regulated by Ref-1, including angiogenesis (VEGF) and inflammation (NF-kB), to decrease abnormal activation of both angiogenesis and inflammatory pathways.
The 100-subject trial is designed to evaluate the efficacy of APX3330 to improve diabetic retinopathy over 24 weeks.
The study's primary endpoint will evaluate the percentage of subjects with a more than 2 step improvement on the Diabetic Retinopathy Severity Scale score.
Secondary endpoints include evaluating central subfield thickness to assess effects on diabetic macular edema, BCVA, safety, and tolerability.
Price Action: OCUP shares are down 3.07% at $5.68 on the last check Thursday.