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01/08/16 9:49 AM

#198882 RE: DewDiligence #198867

Ocera Announces Complete Plasma Data From Pilot Phase 1 Study for Orally-Available OCR-002 in Development for the Prevention of Chronic Hepatic Encephalopathy



http://ir.ocerainc.com/releasedetail.cfm?ReleaseID=949534
Graphs @:
http://www.globenewswire.com/NewsRoom/AttachmentNg/a8e16308-54a6-438a-8cb6-ea86dd1c0354


The mean maximum concentration (Cmax) of plasma PAA from the three pilot OCR-002 extended-release formulations ranged from approximately 50 to 90µg/mL occurring at various time points over 4 to 9 hours after dosing. For comparison, RAVICTI® produced a mean plasma PAA Cmax of approximately 10µg/mL at 4 to 6 hours after dosing. The plasma PAA data after a single oral dose of 6mL RAVICTI® are consistent with published data in healthy subjects.3,4 In addition, PAA exposure with the extended-release formulations of OCR-002 showed lower inter-subject variability than RAVICTI®.

Plasma profiles of PAGN, the end-product of ammonia scavenging, also demonstrated a similar pattern as the PAA profiles. The mean Cmax of plasma PAGN from the pilot extended-release formulations of OCR-002 ranged from approximately 30 to 45µg/mL occurring at various time points over 4 to 10 hours after dosing. For comparison, RAVICTI® produced a mean plasma PAGN Cmax of about 20 to 25µg/mL at approximately 5 hours. These data are also consistent with the published data in healthy subjects.3,4