Vectura Group has revealed positive data from a Phase II clinical study of 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.
The results of the study demonstrate that VR040 improves the control of movement in patients with Parkinson’s disease and VR040 produced clinically relevant and improvement, compared with placebo, 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, when compared with placebo in the relatively small number of patients tested.
In the study, 55 patients diagnosed with fluctuating idiopathic Parkinson’s disease, were randomised to receive either placebo or VR040 and 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.
Vectura CEO Chris Blackwell said that 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 partners. This completes Vectura’s planned investment in the clinical development of VR040,” Blackwell said.