Vectura Announces Successful Outcome of Second Phase IIb Clinical Study on Inhaled Erectile Dysfunction Product
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- Published on Tuesday, 24 April 2007 04:00
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CHIPPENHAM, UK | Apr 23, 2007 | Vectura Group plc (LSE: VEC) (“Vectura”) today announces the successful outcome of a second Phase IIb clinical study for VR004, its product for the treatment of Erectile Dysfunction (ED). The study demonstrated that VR004 again improved erectile performance, with a rapid onset of action, and was well tolerated. VR004 is Vectura’s proprietary formulation of apomorphine, delivered by oral inhalation to the lungs using Vectura’s AspirairÒ dry powder inhaler (DPI).
The study is the second of two double-blind, placebo-controlled trials designed to assess the safety and efficacy of VR004. It evaluated three fine particle doses (100 µg, 150 µg (common dose with previous study) and 200 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 (quick standing and sitting manoeuvres to expose intolerance to vasodilation), 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. Changes from baseline in positive responses to these questions were the primary endpoints of the study.
The following table shows the percentage of positive answers to SEP 2 and SEP 3, and the change from baseline in positive answers to SEP 2 and SEP 3, recorded over the last 4 week period of the study, for the 241 patients who received at least 6 doses of VR004 or placebo “at home”:
|
|
100 µg |
150 µg |
200 µg |
Placebo |
|
Percentage of “positive” answers to SEP 2 |
71% |
66% |
83% |
61% |
|
Percentage of “positive” answers to SEP 3 |
49% |
45% |
62% |
32% |
|
Change from baseline in “positive” answers to SEP 2 |
13%* |
6%* |
14%* |
-1% |
|
Change from baseline in “positive” answers to SEP 3 |
23%* |
17%* |
29%* |
1% |
*p<0.001 compared to placebo
VR004 resulted in statistically significant improvements for SEP 2 and 3 at all doses when compared to placebo thereby achieving the desired primary endpoints of the study.
The mean onset of erectile function was dose independent, with 60% of patients who responded to VR004 reporting onset of erection within five minutes of dosing, and 85% responding within 10 minutes. Some patients responded within 1 minute of dosing.
Good safety and tolerability of patients to VR004 was demonstrated. No treatment-related serious adverse events were reported. Headache was the most common adverse event, reported by 8/98 patients at the top dose compared with 1/89 on placebo.
Presentations of these results are planned at future scientific meetings.
Vectura intends to seek licensing partners for VR004 prior to commencing pivotal Phase III trials and is currently in discussions with a number of companies who have expressed interest in the product.
Dr Chris Blackwell, Chief Executive of Vectura, said:
“The consistency of the data reported from our Phase IIb clinical studies, involving approximately 600 patients with ED of varied aetiology and severity, further validates our belief that VR004 has potential as a rapidly-acting, safe and effective treatment. The combination of these attributes meets our target profile and provides an opportunity for a highly effective product capable of meeting the needs of patients with ED. These data strengthen the package that supports our on-going discussions regarding the licensing of VR004 prior to Phase III clinical evaluation.”
Alan Riley, MSc, MB, BS, MRCS, FFPM, recently retired 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 clearly 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. It is particularly encouraging that such performance has now been demonstrated in ED patients across two separate clinical studies. In addition, as a dopamine agonist, VR004 may also play a role in treating men unresponsive to PDE V inhibitors or those who are contraindicated from using them.”
SOURCE: Vectura Group plc