GSK Parkinson’s drug impresses at phase III
pharmafile | March 21, 2011 | News story | Research and Development | ADVANCE-PD, GSK, GlaxoSmithKline, IPX066, Impax Pharmaceuticals, Parkinson's disease, Parkinson’s disease
GlaxoSmithKline’s advanced Parkinson’s disease drug IPX066 has impressed in a head to head trial against it nearest rival.
The phase III clinical study, conducted by GSK’s development partner Impax Pharmaceuticals, pitted IPX066 versus the off-patent immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients experiencing motor fluctuations.
The primary endpoint of this study was the percentage of ‘off time’ – the functional state where patients’ medication effect has worn off and there is a return of Parkinson symptoms – during waking hours.
IPX066 demonstrated a 37% decrease in off time from baseline versus a 17% decrease from baseline for IR CD-LD.
The ADVANCED-PD study enrolled 471 subjects on a stable regimen of IR CD-LD who were first entered into a dose-adjustment phase of their IR CD-LD, then switched to open label IPX066 after which they were then randomised to double-blind IPX066 or IR CD-LD.
Subjects switched to IPX066 experienced a total reduction in off time from baseline of more than two hours during the day.
Under the terms of a 2010 development and commercialisation agreement, US-based biotech firm Impax will develop and commercialise IPX066 in the United States and Taiwan, with GSK holding rights to the drug in all other markets throughout the world.
Additional patient-reported outcome endpoints included a significant improvement over IR CD-LD on quality-of-life, one of the main concerns of advanced Parkinson’s disease patients.
Full results from the ADVANCE-PD study will be presented at an upcoming scientific meeting.
Earlier this month GSK announced it was severing a 2007 alliance formed with US neuroscience specialist Targacept for a number of drugs including a candidate for Parkinson’s disease.
The UK pharma firm said this was a strategic decision as it looks to cut down on its neuroscience R&D.
A number of pharma companies are working on new treatments for Parkinson’s disease, including Merck Serono and Belgium pharma firm UCB.
Ben Adams
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