Ocuphire Pharma Investor Day Presentation Deck
DR
DME
Concentration of E3330 in plasma
[/]
70
10
Phase 1 Clinical Trials: PK Data Supporting the ZETA-1 Trial
APX3330 has Oral Bioavailability and a Sustained PK Profile
18
2 3 4
6 7 8
1.
Apexian preclinical data (unpublished)
2. APX3330 Investigator Brochure
3.
Eisai PK clinical data APX CLN 0002
MEAN SEM
Olling :24
~40 µg/ml (240 mg/day) in
human plasma
O~20 µg/ml (120 mg/day) in
human plasma
2 µg/ml in mouse plasma at 2hrs;
25 mg/kg oral single dose
12
13
14
9 10 11
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
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