Intec Pharma shares dive after Parkinson’s trial failure

Intec Pharma’s Parkinson’s gradual release disease drug trial has missed its primary endpoint, causing the biotech’s share price to crash.

Shares in the US biotech fell from an opening price of $3.43 as Nasdaq trading began on Friday to just $0.46 on Monday as a result of the news.

The phase 3 ACCORDANCE trial was testing safety and efficacy of its new formulation of carbidopa and levodopa, using a technology allowing for a more gradual release of the drug into the system over a period of around 12 hours.

Dubbed the “Accordion Pill”, Intec’s technology is designed to reduce the likelihood of “off” periods, where the Parkinson’s symptoms return as drugs designed to increase dopamine levels in the body wear off.

It also aims to reduce the development of motor complications seen with levodopa therapy, which can be disabling and may limit the usefulness of the drug.

ACCORDANCE compared Intec’s Accordion Pill with Merck & Co’s Sinemet (carbidopa+levodopa) but failed to achieve its main goal of a statistically superior reduction of daily “off” time.

Treatment-emergent adverse effects (TEAEs) observed with the Accordion Pill 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.

ACCORDANCE study is a global phase 3 study in adult subjects with advanced PD and was conducted at over 90 clinical sites throughout the US, Europe and Israel.

Prior to a 13-week randomised and double-blinded portion of the study, the ACCORDANCE study had two open label periods of six weeks each during which all patients in these open label periods were first stabilised and then optimised on the active comparator, Sinemet, and then on the Accordion Pill.

The study enrolled 462 patients in the Sinemet titration period to provide for the 320 patients that were randomised into the 13-week, double-blinded portion of the study.

All patients completing the 13-week randomised period were eligible to continue in an open-label extension study in which they receive treatment with the Accordion Pill an additional 12 months. More than 90% of eligible patients elected to enter the extension study.

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.

Secondary endpoints include change from baseline to endpoint in ON time without troublesome dyskinesia during waking hours,

A global impressions endpoint, as recorded by physician and patient,  and change from baseline through endpoint in the Unified Parkinson’s Disease Rating Scale (UPDRS) Score Parts 2 and 3 were also assessed. The Accordion Pill also did not achieve statistical superiority on these endpoints.

Chief medical officer Michael Gendreau said that the company will analyse the full data set to inform its future strategy for the drug.

There is a pressing need for new treatments for Parkinson’s drugs – in 2017 Newron’s Xadago (safinamide) became the first drug to treat the disease to get approval from the FDA in more than a decade.

 

 

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