Vectura announces successful outcome of Phase IIb study for VR004
28 Jun 2006
Vectura announces successful outcome of Phase IIb clinical study on inhaled Erectile Dysfunction product
Chippenham, UK – June 28 2006: Vectura Group plc (LSE: VEC ) ("Vectura") today announces the successful outcome of a Phase IIb clinical study for its product, VR004, for the treatment of Erectile Dysfunction (ED). The study demonstrated that VR004 improved erectile performance with a rapid onset of action that was both durable and well tolerated. VR004 is Vectura's proprietary formulation of apomorphine, delivered by oral inhalation to the lungs using Vectura's Aspirair® dry powder inhaler (DPI).
The study is the first of two double-blind, placebo-controlled trials designed to assess the safety and efficacy of VR004 . The study evaluated three fine particle doses (150 µg, 250 µg and 300 µg) and placebo in patients with mild, moderate or severe ED. Following a four week "no treatment" run-in period, patients were randomised to either placebo or VR004. On successful completion of an orthostatic challenge, patients were allowed home with study treatment for a period of 12 weeks.
The assessment of efficacy used the Sexual Encounter Profile (SEP) questions 2 and 3. SEP 2 is a measure of the ability of a patient to achieve vaginal penetration. SEP 3 assesses the ability of a patient to maintain an erection suitable for successful intercourse.
The study primary endpoints measured changes in SEP 2 and SEP 3 from pre-treatment baseline to the last 4 weeks of study treatment. In addition, patients were requested to record the time to onset and the duration of erection.
The following table shows the percentage of positive answers to SEP 2 and SEP 3 in the last 4 weeks of treatment, and the change in positive answers to SEP 2 and SEP 3 from baseline to the last 4 weeks of treatment, for the 138 patients who received at least 6 doses of VR004 "at home":
| 150 µg | 250 µg | 300 µg | Placebo | |
| Percentage of "positive" answers to SEP 2 in last 4 weeks of treatment | 69% | 87% | 79% | 60% |
| Percentage of "positive" answers to SEP 3 in last 4 weeks of treatment | 46% | 60% | 62% | 38% |
| Change in "positive" answers to SEP 2 from baseline to last 4 weeks of treatment | 8% * | 30% * | 25% * | -4% |
| Change in "positive" answers to SEP 3 from baseline to last 4 weeks of treatment | 14% | 26% * | 28% * | 6% |
* p<0.05 compared to placebo
VR004 resulted in statistically significant improvements for SEP 2 at all doses when compared to placebo. For SEP 3, statistically significant improvements were achieved at the middle and high doses. The mean onset of erectile function was dose independent, with 50% of patients, who responded to VR004, reporting onset of erection within five minutes of dosing, and over 80% responding within 10 minutes. Some patients responded within 1 minute of dosing.
No serious adverse events were reported. The profile of adverse events for all treatments, including placebo, was similar. Headache was the most frequently reported adverse event (5%) across the study population. Less than 3% of patients reported dizziness and only 1 patient reported nausea. No clinically relevant changes in mean lung function over the study treatment period were reported. In response to orthostatic challenge (quick standing and sitting manoeuvres to expose intolerance to vasodilation), 4 patients experienced decerease in blood pressure that resolved without further problems. As a consequence of a review of these patients' data, and as a precaution for the remainder of the study, randomisation of further patients to the two top doses was stopped. However, patients already successfully randomised to these doses were allowed to continue "at home" treatment and the unblinded data analysis for these doses supports their consideration for selection in the next stage of development of VR004.
Vectura's second dose-defining Phase IIb study is underway and will evaluate fine particle doses of 100 µg, 150 µg and 200 µg in up to 250 patients. This second study is due to report in H1 2007.
Dr Chris Blackwell , Chief Executive of Vectura, said:
"The results of this study validate our belief that VR004 has potential as a rapidly-acting, safe and effective treatment. The combination of these attributes meets our target profile and the unmet need for a spontaneous product, providing activity on demand for patients with ED. These data are also of value in our strategy to licence the product to a development partner prior to Phase III. In addition, the study provides further validation of the effectiveness of our Aspirair® dry powder inhaler device."
Alan Riley, MSc, MB, BS, MRCS, FFPM, Professor of Sexual Medicine at Lancashire School of Health and Postgraduate Medicine, University of Central Lancashire, and Principal Investigator of the study, commented: "The results of this study demonstrate that apomorphine administered by inhalation not only provides a product with therapeutic benefit in ED similar to that seen previously with the PDE V inhibitors, but also brings clear benefits of speed of action and spontaneity."
Enquiries
Vectura Group plc +44 (0) 1249 667 700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Financial Dynamics +44 (0) 207 831 3113
David Yates/Sarah MacLeod/John Gilbert
Notes for Editors
About erectile dysfunction
ED is defined as the consistent inability to achieve and/or maintain an erection adequate for satisfactory sexual function. The condition is correlated with increasing age, cardiovascular disease, hypertension, diabetes, obesity, hyperlipidaemia and smoking. In addition, neurogenic risk factors resulting from radical prostatectomy, spinal cord injury and multiple sclerosis as well as certain prescription drugs and psychogenic issues contribute to ED.
ED affects more than 50 million men in the US and EU with 2005 global sales of approximately $2.6 billion and is expected to be $4.4 billion a year by 2010. Through market research with doctors, patients and opinion leaders, we believe that there is a clear unmet need for products with a faster onset of action than current oral and buccal products. Continued market growth will be driven by a number of factors, including the ageing population, the awareness amongst patients and their partners about the availability of effective ED treatments and the increasing prevalence of predisposing factors such as cardiovascular disease and obesity. The market is currently dominated by the PDE V inhibitors Viagra, Cialis and Levitra.
Based on the clinical trials to date, it is anticipated that apomorphine delivered through the lungs will be more efficient; avoiding first-pass metabolism, thus requiring lower nominal doses and providing a faster onset of therapeutic activity than drugs delivered orally, sub-lingually or intra-nasally.
About Vectura
Vectura’s principal focus is the development of a range of inhaled drugs for the treatment of both lung diseases and other conditions where optimised delivery via the lungs can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
Vectura's products combine its proprietary, innovative, pulmonary formulation and device technologies (Aspirair ® GyroHaler ® and PowderHale ® ) with existing, off-patent drugs either for use in new indications or to provide inhalation as an improved route of administration. Using drugs that have already been approved in some form in at least one major pharmaceutical market lowers the risk of product development failure compared to new chemical entities, Vectura is able to secure patent protection for its portfolio by identifying new indications for off-patent compounds and applying the Company's proprietary delivery technologies to create new methods of administration. The Company has development collaborations with a number of companies, including Boehringer Ingelheim, Novartis, GSK and Chiesi and an un-named leading international pharmaceutical company.
For further information, please visit Vectura's website at www.vectura.com
