July 21, 2003
Vectura Limited, the UK-based speciality pharmaceuticals company, announced today the successful completion of a Phase IIa clinical study for its product, VR004 (inhaled apomorphine HCl), for the treatment of Erectile Dysfunction (ED). The study showed that VR004 improved erectile performance with a rapid onset of action and demonstrated excellent tolerability at all doses tested. Additional studies to progress the clinical development of VR004 will be initiated in the near future. Vectura is pursuing licensing discussions with interested parties with a view to completing this process by the end of 2003.
"In a market where spontaneity is so important, the opportunity to provide such a well-tolerated, effective, and rapidly acting product, will clearly be of benefit to patients," commented Vectura's CEO, Peter Virley. "The results of this study are also of broader value to Vectura, since we have now proved the clinical concept for our formulation and device technologies in providing improved performance when delivering a systemically-active drug through the lungs."
VR004 is inhaled and absorbed into the systemic circulation via the lungs. It is anticipated that delivery of drugs through the lungs will be more efficient; avoiding first-pass metabolism, requiring lower nominal doses and providing a faster onset of therapeutic activity than drugs delivered orally, sub-lingually or intra-nasally.
The study evaluated the efficacy of, and tolerability to, 200 micrograms, 400 micrograms and 800 micrograms doses of VR004 in 35 patients with mild to moderate ED, in a placebo-controlled, escalating dose design. Doses were administered as dry powder formulations using Vectura's Aspirair(TM) device. Aspirair(TM) is a highly efficient, breath-actuated dry powder inhaler that does not rely upon co-ordination of device actuation with patient inhalation.
Erectile performance was assessed in response to visual stimuli in a clinic setting using a modified version of Question 4 of the International Index of Erectile Function (IIEF) questionnaire.
The study demonstrated that, at doses of 400 micrograms and 800 micrograms, VR004 improved erectile performance compared with placebo. The proportion of patients achieving Grade 3 or 4 erectile performance at these doses (indicating erections of sufficient quality for intercourse) was 49% and 59% respectively (placebo, 31%). The response rate following the 200 micrograms dose was 23%.
The onset of erections was notably rapid, with median onset times of 8 minutes following the 400 micrograms and 800 micrograms doses. The most rapid responses occurred in some patients 3 minutes after they received 400 micrograms or 800 micrograms doses.
Excellent tolerability was observed at all doses. No serious or severe adverse events were reported. All treatment related adverse events were mild or moderate. None of the patients discontinued the study as a result of treatment.
Vectura was founded by Merlin Biosciences in 1997 and has already established itself as a leading European provider of innovative inhaler formulations for pulmonary drug delivery. The Company is developing a portfolio of enhanced-performance pharmaceutical products based on its patent-protected drug delivery technology platforms. Vectura is targeting specific product development opportunities in the areas of chronic obstructive pulmonary disease (COPD), sexual dysfunction, epilepsy, cystic fibrosis and asthma. The Company has development collaborations with GSK, Chiesi, Arakis, Zambon and Ranbaxy. Vectura employs 100 people at sites in Chippenham and Cambridge. Its major shareholders are Merlin funds, ISIS funds, the University of Bath and its management.
About Erectile Dysfunction
ED is defined as the consistent inability to achieve and/or maintain an erection adequate for satisfactory sexual function. ED affects an estimated 152 million men and their partners worldwide (Aytac et al, British Journal of Urology, 1999). The ED market is expected to have peak sales of over 6 billion dollars worldwide (Deutsche Banc Alex Brown, June 2001). The condition is correlated with increasing age, cardiovascular disease, hypertension, diabetes, hyperlipidaemia and smoking. In addition, neurogenic risk factors such as radical prostatectomy, spinal cord injury and multiple sclerosis, certain prescription drugs, and psychogenic issues may contribute to ED.
The IIEF is a validated questionnaire used for the evaluation of erectile
performance and other indices of erectile dysfunction (Rosen et al.
International Index of Erectile Function (IIEF): a multidimensional
assessment of erectile dysfunction. Urology 49: 822-830). It
has been used as
a primary outcome variable in studies that have formed the basis of
dossiers for approved ED products.
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