A phase 3 trial of Intec Pharma’s Parkinson's disease drug has missed its primary endpoint, sparking a steep decline in the company’s stock. The candidate uses a drug delivery system designed to improve on Merck’s Sinemet but was unable to beat the established product in a late-phase test.
Levodopa-based drugs such as Sinemet treat the symptoms of Parkinson’s, but their efficacy declines over time, leading to off episodes in which motor symptoms reappear. Intec sought to cut the time patients spend in off episodes by delivering levodopa in a technology designed to extend its release into the stomach to up to 12 hours.
Israel’s Intec thought extending the release of levodopa would reduce the time patients spend in off episodes. The late-phase clinical data on the candidate, dubbed AP-CD/LD, say otherwise.
After randomizing 320 patients to receive either Sinemet or the extended-release formulation for 13 weeks, Intec analyzed patient-reported data on the time spent in off episodes. The analysis showed the extended-release formulation, which uses the same active ingredients as Sinemet, was no better than Merck’s drug. The trial was 90% powered to detect a one-hour difference between the arms.
The secondary endpoint data were similarly lackluster. AP-CD/LD was no better than Sinemet on two symptom scales, and it failed to improve on the on time without troubling dyskinesia achieved by the Merck drug.
Faced with the wall-to-wall failure, Intec highlighted safety data and performance in a subgroup as the positives to emerge from the trial.
"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. 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," Intec Chief Medical Officer R. Michael Gendreau said in a statement.
Investors were in no mood to take the positives. Intec’s stock dropped 77% in premarket trading, adding to the 24% decline it suffered last week. The stock is now at the lowest level since Intec came to the Nasdaq in 2015 through a downsized $30 million IPO. Intec ended March with $31 million in cash and equivalents.