Intec Pharma reports top-line phase III trial results of Accordion Pill-Carbidopa/Levodopa inadvanced Parkinson's disease

Intec Pharma Ltd. announces top-line data from the Company's pivotal Phase III 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, which can be disabling, difficult to treat, and may limit the usefulness of the drug. OFF periods and dyskinesia are some of the most prevalent motor complications for advanced PD patients and they have a significant impact on quality-of-life and healthcare costs.

Key Findings of the ACCORDANCE Trial : AP-CD/LD provided treatment for Parkinson's disease symptoms but did not demonstrate a statistically significant reduction in OFF time over that obtained with IR-CD/LD under the conditions established in the protocol. Treatment-emergent adverse effects (TEAEs) observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations and no new safety issues were observed throughout the double-blinded study, during the gastroscopy safety sub-study or the 12-month open-label extension (OLE) study.