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Vectura announces successful outcome of second phase IIb clinical study on VR004

Vectura announces successful outcome of second Phase IIb clinical study on inhaled Erectile Dysfunction product

Chippenham, UK – 23 April, 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”:

*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.”

Enquiries:

Vectura Group plc Tel: + 44 (0) 1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer

Financial Dynamics Tel: + 44 (0) 207 831 3113
David Yates / 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 2006 global sales in excess of $2.9 billion and with global sales expected to be $6.6 billion by 2012. 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 the first Phase IIb VR004 study
Results from the first VR004 Phase IIb study were published on 28 June 2006 and the comparable table, for the doses used in this study, showing 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 138 patients who received at least 6 doses of VR004 or placebo “at home” in this first study is as follows:

*p<0.05 compared to placebo

As with the second trial the mean onset of erectile function was dose independent, with 50% of patients in the first trial, who responded to VR004, reporting onset of erection within five minutes of dosing, and over 80% responding within 10 minutes.

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 strategy is to combine its proprietary pulmonary formulation and device technologies with existing, off-patent or clinically validated drugs either for use in new indications or to provide inhalation as an improved means of administration. The Company has a portfolio of products in pre-clinical and clinical development, some of which have been licensed to major pharmaceutical companies. It also generates revenue from partnerships in respect of marketed pulmonary and non-pulmonary products. Vectura also actively licenses out its inhalation device and formulation technologies for product applications of other pharmaceutical companies.

The Company has development collaborations with Boehringer Ingelheim, Novartis, GSK and Chiesi as well as with other non-disclosed pharmaceutical companies. The acquisition by Vectura in January 2007 of Innovata added further development and licensing partnerships including, Baxter, UCB and Otsuka as well as expanding its range of inhalation technologies and development programmes. For further information, please visit Vectura’s website at www.vectura.com

About Aspirair®
Aspirair is Vectura’s high performance, patent-protected inhaler technology, designed to allow delivery with high lung penetration and low variability, essential for drugs that are intended for systemic delivery. Vectura believes that t he device is conveniently sized and simple to use compared to other ‘active’ inhalers. Experiments to date indicate that Aspirair is capable of delivering DPI formulations of both large and small molecules, either in the form of a pure drug particle or in combination with an excipient. In laboratory tests, Aspirair has been shown to consistently deliver both fine and ultra-fine particles to the deep lung regions. Aspirair generates an aerosol plume, triggered by a patient’s inhalation, which is significantly slower than most spray type active inhalers currently available. This reduces the amount of drug that is unintentionally deposited in the mouth and throat and subsequently swallowed rather than inhaled into the lungs. The Aspirair device is currently manufactured in pilot-scale quantities under GMP conditions by CTP Plasro, while blister filling takes place at Vectura’s own GMP facility in Chippenham. Aspirair has been used in patient studies in clinic and at-home settings by more than 600 subjects.