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Intec Pharma Announces Positive Results From Pharmacokinetic Study

Intec Pharma Ltd. (NTEC) announced the preliminary results from a pharmacokinetic or PK study comparing the Company's Accordion Pill Carbidopa/Levodopa (AP-CD/LD) 50/500mg dosed three times daily or TID to 1.5 tablets of CD/LD immediate release (Sinemetâ„¢) 25/100 dosed five times per day in Parkinson's disease or PD patients.

The company plans to submit the full data set for potential presentation and publication at a major medical meeting and in a peer review journal, respectively.

The object of this open-label, crossover PK study was to compare the plasma levodopa variability in 12 PD patients treated with standard levodopa therapy and with AP-CD/LD 50/500 mg TID. On Day one, all participants received 1.5 tablets of standard Sinemet 25/100 mg five times at approximately three-hour intervals.

Advanced Parkinson's patients often receive more than three doses per day of standard levodopa therapy such as Sinemet. Plasma was collected for PK determination at 30-minute intervals for 16 hours in the clinic. This period provided the reference PK profile for Sinemet. On Days two through seven, PD patients were treated at home with AP-CD/LD 50/500 mg capsules dosed TID, at approximately five-hour intervals. On Day eight, participants returned to the clinic and PK assessments were repeated.

The primary outcome measure in this study was the fluctuation index [(Cmax-Cmin)/Cavg] in plasma levodopa concentration at steady state (between hours four and 16.) The key secondary endpoint was the levodopa coefficient of variation.

AP-CD/LD 50/500 mg TID met its primary endpoint demonstrating significantly less variability than standard oral CD/LD when dosed 5x/ day in the levodopa fluctuation index (p<0.005). These results were supported by the findings of significant outcomes on each of the prespecified sensitivity analyses. Similar results were observed for the key secondary endpoint of coefficient of variation of plasma levodopa levels (p<0.047). AP-CD/LD was very well tolerated with no reported adverse events

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