10 Oct 2008 12:30
| Press Release | 10 October 2008 |
e-Therapeutics plc
("e-Therapeutics" or the "Company")
Positive Phase IIa clinical trial of the Company's oral asthma treatment
e-Therapeutics plc (AIM: ETX), the drug discovery and development company, is pleased to announce the successful conclusion of the Company's Phase IIa clinical trial of ETX9101, a new oral treatment for asthma which has the potential to reduce exacerbation of asthma and to reduce the intake of inhaled corticosteroids and bronchodilators, thereby reducing their side-effects.
Asthma affects between 5% and 15% of children and adults worldwide. The prevalence of this condition is rising by circa 5% - 6% per annum. Currently, an estimated US$15 billion are spent annually on asthma treatments.
The single centre, randomised, open label, comparative and parallel trial was designed to compare the effects on incidence of asthma exacerbations, symptomatology, changes in the consumption of beta-2 agonists and corticosteroids, and unscheduled healthcare visits for asthma among patients, with and without ETX9101, over a period of 12 weeks. Patients selected for the trial were aged between 18 and 65 years with persistent asthma. The sample size was 40 patients, with half receiving ETX9101 in addition to their established inhaled asthma medication regime (the treatment group), and the other half receiving their established inhaled asthma regimen alone (the control group). The trial was conducted in the Outpatient Department of St. John's Medical College Hospital, Bangalore, India, which is a major centre, under the supervision of Professor G. D'Souza.
The outcome of the trial was that ETX9101 abolished asthma exacerbations in the treatment group, diminished the need for inhaled relief medicine, and was well tolerated by patients. Additionally, they felt more comfortable during the night.
Dr Royston Drucker, e-Therapeutics' Chief Medical Officer said: "We're delighted by these results. ETX9101 met all the trial end-points: the drug combination headed off asthma exacerbations, reduced the need for inhalers, which burden many patients with adverse effects, and made asthmatics more comfortable, especially at night. ETX9101 can now go forward to a larger trial involving a patient population with more severe asthma, in which a higher incidence of exacerbations could be anticipated. If the medicine continues to deliver as it has in this trial, this could become routinely prescribed to many asthmatic patients."
Professor Malcolm Young, the e-Therapeutics CEO, commented: "We are very pleased to have achieved a potentially important breakthrough in the treatment of asthma. Not a single asthmatic who has taken our drug suffered an exacerbation. This is a major milestone both in the development of ETX9101 and for the Company's drug discovery platform. We are now looking toward continuing the commercialisation of this product with our licensing partners."
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Notes to Editors
e-Therapeutics plc is a systems biology drug discovery company. It has developed proprietary computational systems to swiftly and accurately analyse and predict how medicines interact with cells in the body. This optimises the probability of identifying drug candidates with desirable efficacy and low toxicity. The Company applies its novel, systematic approach to three areas of activity:
| discovery of new drugs; | |
| discovering novel uses for existing drugs; and | |
| analysis of the interactions between different drugs. |
Amongst e-Therapeutics' pipeline of compounds in development are novel antibiotics that have been shown to kill the "superbug" MRSA, and a novel cancer chemotherapy that has been shown to kill malignant cells at safe doses in a very short time. Other candidate therapies in development are targeted at atherosclerosis, asthma and depression. The Company is currently in negotiation with a number of pharmaceutical companies, and is progressing the preclinical and clinical development of these products.
Please refer to the project announcements at the Company's website (www.etherapeutics.co.uk) for further information on Company operations.