Plus   Neg

Intec Says Phase 3 Trial Did Not Achieve Statistical Superiority To Sinemet

Intec Pharma Ltd. (NTEC) announces Monday top-line data from the Company's pivotal Phase 3 ACCORDANCE trial evaluating the safety and efficacy of the Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet) as a treatment for the symptoms of advanced Parkinson's disease (PD).

The company announced that the ACCORDANCE study did not achieve statistical superiority to Sinemet on the primary endpoint of reduction in daily OFF time.

Levodopa is the most widely used and most effective drug for the symptomatic therapy of PD. However, chronic levodopa therapy is problematic due to the development of motor complications and may limit the usefulness of the drug.

The Phase 3 ACCORDANCE study is a multi-center, global, 13-week randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with advanced PD. The study was conducted at over 90 clinical sites throughout the U.S., Europe and Israel.

The primary efficacy endpoint of the study was the change from baseline to endpoint in the percent of daily OFF time during waking hours based on Hauser home diaries.

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