Intec Pharma (NASDAQ:NTEC) reported that its Accordion Pill carbidopa/levodopa (AP-CD/LD) failed to meet its primary endpoint in a Phase 3 trial for Parkinson’s disease (PD).
Intec’s extended release AP-CD/LD failed to demonstrate superiority to Sinemet, an FDA-approved immediate release CD/LD pill. Although AP-CD/LD treated PD symptoms, it did not demonstrate a statistically significant reduction in episodes of dyskinesia, stiffness and rigidity – referred to as OFF time – when compared with Sinemet.
“Upon our on-going preliminary review of the data, we have noted that certain subsets of patients performed particularly well. In those patients, we see a meaningful reduction in OFF time,” Dr. Michael Gendreau, Intec’s CMO, said in a statement.
“We will continue to analyze the full data set and expect that such findings will help inform our strategy for AP-CD/LD moving forward,” he added.
