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Ocuphire Pharma Results

Plasma concentration of APX3330² 70 60 50 40 30 20 10 Phase 1 Clinical Trials: PK Data Supporting the ZETA-1 Trial APX3330 has Oral Bioavailability and a Sustained PK Profile 1 2 3 Ocuphire PHARMA MEAN+SEM O120 mg Apexian preclinical data (unpublished) APX3330 Investigator Brochure Eisai PK clinical data APX_CLN_0002 240 mg ~40 µg/ml (240 mg/day) in human plasma ~20 µg/ml (120 mg/day) in human O plasma 2 µg/ml in mouse plasma at 2hrs; 25 mg/kg oral single dose 10 11 12 13 14 15 Time[day] Favorable Oral Bioavailability Sustained Pharmacokinetic Profile Tmax 3-4 hours Linear dose-proportional PK Dose-proportional increase in Cmax/AUC exposure Half-life elimination of 45 hours (steady state [SS] 5-6 days) Meals have no clinically meaningful impact on the PK of orally administered APX3330 Sufficient APX3330 Exposure Plasma levels observed after 120 and 240 mg/day dosing is multiple times higher than what was required for efficacy in preclinical studies planned clinical dose is 600 mg/day 38
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