VEC16 Nov 2010 07:10
Positive outcome for VR040 in Parkinson's trial
Statistically significant improvement in symptoms
Rapid onset of therapeutic benefit
Chippenham, UK - 16 November 2010: Vectura Group plc ("Vectura"; LSE: VEC) today announces positive data from a Phase II clinical study for its inhalation product, VR040, for the treatment of "off" episodes (periods of inability to control movement) in patients with fluctuating Parkinson's disease. VR040 is Vectura's proprietary formulation of apomorphine, delivered to the bloodstream by inhalation through the lungs using the Company's proprietary dry powder inhalation (DPI) technology. VR040 was designated an orphan drug by the European Medicines Agency (EMA) and is being developed using the EMA scientific advice procedure.
The results of the study demonstrate that VR040 improves the control of movement in patients with Parkinson's disease. VR040 produced clinically relevant and statistically significant improvement, compared with placebo (p=0.023), of the Unified Parkinson's Disease Rating Scale Part III (UPDRS III), a measure of a patient's ability to control movement (see Notes for editors).
VR040 also reduced the time patients were in an "off" state by over 2 hours, a change considered by the investigators to be highly clinically relevant, although not statistically significant (p=0.078), when compared with placebo in the relatively small number of patients tested. The mean onset of therapeutic benefit was rapid, with patients converting to an "on" state in less than 9 minutes after taking VR040, with some patients responding just one minute after receiving their dose. VR040 was well tolerated with no reports of severe adverse events.
Fifty-five patients, diagnosed with fluctuating idiopathic Parkinson's disease, were randomised to receive either placebo or VR040. Patients were rapidly titrated to a dose of VR040 that elicited a therapeutic response and continued to use this dose in the home setting to treat "off" episodes.
Dr Donald Grosset, BSc (Hons), MBChB, MD, Consultant Neurologist in the Institute of Neurological Sciences, Southern General Hospital, Glasgow, UK and Principal Investigator of the study, commented:
"The study was a first opportunity to evaluate inhaled apomorphine in the home environment with patients reporting clinically significant reductions in their mean daily off time. It is reassuring to see that the safety and therapeutic benefit of VR040 have now been reproduced across three separate trials in 126 Parkinson's disease patients."
Dr Chris Blackwell, Chief Executive of Vectura, added:
"This study confirms the potential therapeutic benefit of VR040 to Parkinson's patients, and in three separate studies, that it is a safe, easy to use and non-invasive treatment. These data will also be of value in ongoing discussions with prospective licensing pa