Vectura announces successful outcome of second Phase II clinical study from Parkinson’s disease programme
31 October 2007
Vectura announces successful outcome of second Phase II clinical study from Parkinson’s disease programme
Chippenham, UK – 31 October 2007: Vectura Group plc (“Vectura”; LSE: VEC) today announces positive data from a Phase II clinical study for its product, VR040, for the treatment of "off" episodes, debilitating periods of complete or partial immobility, in patients with Parkinson's disease. VR040 is Vectura's proprietary formulation of apomorphine, delivered to the bloodstream by oral inhalation through the lungs using the Company’s proprietary dry powder inhalation (DPI) technology.
The study demonstrated:
· Statistically significant improvement in the primary endpoint of mean change in Unified Parkinson Disease Rating Scale III (UPDRS III) relative to that seen with placebo (p=0.016)
· High restoration of mobility, allowing 81% of patients to achieve responses essentially the same as those achieved with their usual levodopa dose
· Rapid onset of action; the majority of patients achieved conversions within 10 minutes of inhaling apomorphine. Some patients reported conversion as quickly as 2 minutes after taking their medication
· Durability of response, with a mean duration of 75 minutes
· Excellent tolerability with only 5 of 32 patients reporting a total of 7 treatment-related adverse events; no reports of treatment-related serious or severe adverse events and no patient withdrawals resulting from safety concerns
The randomised, double-blind, placebo-controlled study evaluated the safety and efficacy of four different VR040 fine particle doses up to 3.2 mg. Forty-seven patients, diagnosed with idiopathic Parkinson’s disease, were randomised to receive either placebo or active treatment. On visiting the clinic, a patient's conventional treatment was stopped temporarily and an "off" episode induced. Each patient then received increasing VR040 doses or placebo equivalent, until a therapeutic response approximately equivalent to that measured with their usual levodopa dose was recorded.
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 data support the clinical effectiveness of VR040 in Parkinson’s disease. This new, non-invasive way of delivering apomorphine quickly and efficiently to the bloodstream translates into a very rapid onset of action. This, together with the lack of side effects, means VR040 should provide benefit to Parkinson’s disease patients as their disease progresses."
Dr Chris Blackwell, Chief Executive of Vectura, added: "The results of this study confirm our original enthusiasm for VR040’s potential. VR040 represents a breakthrough in providing a rapid onset of action, which is also durable. Importantly, our novel delivery route, via inhalation, also offers patients an improved alternative to the currently available formulations of apomorphine. The next stage in VR040 clinical development will focus on determining optimal titrated dosing in an ‘at home’ setting.”
- Ends -
Enquiries:
Vectura Group plc +44 (0)1249 667 600
Dr Chris Blackwell
Anne Hyland
Julia Wilson
Financial Dynamics +44 (0)20 7831 3113
David Yates
Sanjeev Pandya
Notes for Editors:
About Parkinson’s disease
It is estimated that approximately 1 million people in Europe and 1.5 million people in the US have PD. Approximately 10% of these experience severe on/off motor fluctuations which require apomorphine treatment. PD is a progressive neurological disorder that leads to the loss of dopamine containing neurons in the basal ganglia of the brain. People with PD often experience trembling, muscle rigidity, and difficulty walking. As the disease progresses, therapeutic control diminishes and patients experience motor complications ("off" episodes) which become more frequent, and severe, and are disabling and often of sudden onset. VR040 aims to provide rapid, non-invasive relief from such symptoms.
About UPDRS
The Unified Parkinson Disease Rating Scale (UPDRS) rates a patient across 31 separate items, each with a score of 0-4. The rating scale covers three areas: mentation, behaviour and mood (4 items); activities of daily living (13 items); and motor examination (14 items). The latter component, UPDRS III, is routinely employed across clinical studies to measure changes in motor function as a result of treatment administration.
About the first Phase II “proof of concept” VR040 study
Results from the first VR040 clinical study which was a proof of concept study were published on 8 August 2006. The study evaluated six actual fine particle doses (170µg, 255 µg, 435 µg, 653 µg, 710 µg, 1065µg) and placebo in 24 PD patients who experience "off" episodes. Whilst the study was not powered for meaningful statistical comparisons, five patients converted to a full "on" state having inhaled VR040, compared with one patient following inhalation of placebo.
About Vectura
Vectura is a pulmonary drug development company focused principally on the development of a range of inhaled therapies for the treatment of respiratory and neurological diseases.
Vectura develops products to treat respiratory diseases such asthma, COPD and cystic fibrosis. The respiratory market is forecast to achieve sales of $32 billion by 2011.
Vectura also develops products where optimised delivery via the lungs into the blood stream can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
Vectura has eight marketed products and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. The Company also seeks to develop certain programmes further through development to optimise value at a later licensing stage. Vectura also offers its formulation and inhalation technologies to other pharmaceutical companies on a licensing basis where this complements Vectura’s business strategy.
Vectura has development collaborations with a broad range of pharmaceutical companies including Boehringer Ingelheim, Novartis, and Chiesi. The acquisition of Innovata in January 2007 brought established alliances with a number of additional companies, such as Baxter, GSK, Merck Generics (part of Mylan Inc), UCB and Otsuka as well providing revenue streams, complementary products and critical mass.
For further information, please visit Vectura’s website at www.vectura.com
Vectura Forward Looking Statement
This press release contains “forward-looking statements,” including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura’s actual results to differ materially from those expressed or implied by the forward-looking statements, including adverse results in clinical development programs; failure to obtain patent protection for discoveries; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
