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Intec Shares Slammed As Advanced Parkinson's Disease Drug Combo Flunks Late-Stage Study

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Intec Shares Slammed As Advanced Parkinson's Disease Drug Combo Flunks Late-Stage Study

Micro-cap Intec Pharma Ltd (NASDAQ: NTEC) shares are plummeting on heavy volume Monday following a clinical trial readout from the company.

What Happened

Intec, a clinical-stage biotech that develops drugs based on its proprietary Accordion Pill platform technology, said top-line data from a pivotal Phase 3 trial dubbed ACCORDANCE did not achieve the primary endpoint.

The study evaluated the safety and efficacy of the Accordion Pill – Carbidopa/Levodopa compared with immediate release Carbidopa/Levodopa for treating symptoms of advanced Parkinson's disease, with a reduction in daily OFF time being the primary endpoint.

OFF periods are time when dopamine in the brain goes low and when Levopoda – the current standard of care for Parkinson's disease – doesn't work.

The Accordion Pill formulation didn't achieve statistical superiority to the immediate release version, the company said.

However, treatment-emergent adverse effects observed with the Accordion Pill formulation were generally consistent with the known safety profile of Carbidopa/Levodopa formulations, with no new safety issues observed throughout the double-blinded study.

Why It's Important

The Accordion Pill formulation of Carbidopa/Levopoda Intec's pipeline candidate that is in the most advanced stage of development.

As of now a majority of Parkinson's disease patients are treated with Levopoda, and treatment with Levopoda is often associated with motor complications, mainly wearing OFF period and LD-induced dyskinesia.

Parkinson's disease is the second most common neurodegenerative disorder in the elderly, estimated to affect more than two million people in the U.S. and Europe, Intec said.

What Next

Intec's ongoing preliminary review of the data, revealed certain subsets of patients performed particularly well, experiencing 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," said Michael Gendreau, Chief Medical Officer.

Intec was plunging 85% to 45 cents per share at time of publication.

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