Ocuphire initiates phase 2 trial of oral diabetic retinopathy treatment
Ocuphire Pharma has initiated a phase 2 clinical trial investigating APX3330 in nonproliferative and mild proliferative diabetic retinopathy, according to a press release.
ZETA-1, a randomized, placebo-controlled, double-masked study, will investigate the efficacy of APX3330 over 24 weeks. The primary endpoint is the percentage of patients with a two or greater step improvement on the Diabetic Retinopathy Severity Scale. Secondary endpoints include an evaluation of central subfield thickness “to assess effects on diabetic macular edema, [best corrected visual acuity], safety and tolerability,” the release said. The study will include about 100 patients.
APX3330, a small molecule oral drug candidate, inhibits transcription factor regulator Ref-1, the release said. The therapy works by blocking downstream pathways maintained by Ref-1 to “decrease abnormal activation of both angiogenesis and inflammatory pathways.” The pathways affect several retinal diseases such as diabetic macular edema, age-related macular degeneration and diabetic retinopathy, the release said.
“Building off of 11 prior trials that have demonstrated a favorable safety and tolerability profile in over 300 oncology and hepatic patients, APX3330 has the potential to become the first oral therapy used for diabetic retinopathy,” Mina Sooch, MBA, president and CEO of Ocuphire, said in the release.