ATL-962: A Gastro-Intestinal Lipase Inhibitor will Help Fight Obesity
Feb 1, 2005 - 9:39:00 AM
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By Akanksha,Pharmacology Correspondent,
[RxPG] Alizyme plc has opened an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a clinical trial in the USA of ATL-962 in obese subjects.
The trial is a randomised double-blind, parallel-group, repeat-dose pharmacokinetic and pharmacodynamic study. Approximately 80 obese subjects with a Body Mass Index (BMI) of between 30 and 45 will be enrolled, with subjects receiving one of four dose levels of ATL-962 three times daily for 14 days.
The study will provide data on faecal fat levels, safety and tolerability in North American obese subjects. Results are expected to be available around the end of 2005.
The opening of an IND for ATL-962 allows Alizyme to discuss the development of the product with FDA in preparation for Phase III studies and ultimately for registration in the USA.
ATL-962, an inhibitor of gastro-intestinal lipases, is designed to cause weight loss by blocking the digestion and thus the absorption of fat from the diet.
Patient recruitment is also ongoing in Europe for a Phase IIb clinical trial of ATL-962 in obese diabetics. This study in up to 600 patients, which has a Xenical® comparator arm in the design, is expected to report results at the end of 2005.
Xenical®,which was launched by Roche,also inhibits lipase (a fat splitting enzyme in the digestive tract) to reduce fat absorption. This leads to fewer calories being absorbed, thus resulting in weight loss. It was first approved in 1997 and is now marketed in more than 100 countries with current sales of approximately $500 million per annum.
Commenting, Dr Richard Palmer, Chief Executive Officer said,We are extremely pleased to open the IND for ATL-962 and look forward to further discussions with FDA concerning the development programme in the USA. This is an important step forward for this product in its development for the commercially significant USA market.
Obesity is a poorly understood disease.It is considered to be a complex syndrome involving many different physiological processes. What is clear is that health risks increase as the degree of obesity increases. In particular, there is an increased risk of Type II diabetes, cardiovascular and joint diseases. These health risks are substantially reduced with loss of weight. Obesity and these associated conditions are chronic and therefore, have major consequences for healthcare spending. Conservative estimates of the economic costs of obesity range from 2% to 8% of the total costs of healthcare of the developed world. The National Institutes of Health (NIH) indicate that healthcare costs attributable to obesity in the US are approximately $100 billion annually.
The incidence of obesity has shown a substantial increase over the past twenty years. The World Health Organisation (WHO) has identified obesity as an epidemic and as the largest global, chronic health problem in adults. In 2003, the WHO estimated that worldwide, over 300 million adults are estimated to be clinically obese (Body Mass Index over 30 - see below for definition) or 28 with co-morbidities, while 1 billion are overweight. Figures for the UK show the problem is increasing with 13.2% and 17.0% of men and 16.4% and 19.7% of women, in 1993 and 1997 respectively, being classified as clinically obese. Although the disease is becoming high profile, as it is increasingly being recognised as a treatable disease, the market currently represents a substantial unmet medical need.
Drug treatment is being recommended for individuals with a Body Mass Index of over 30.In the past,treatments have included appetite suppressants or bulking agents.
Lipase inhibitors tend to reduce fat absorption.This leads to fewer calories being absorbed, thus resulting in weight loss.
Weight loss with lipase inhibitors significantly improves various risk factors for cardiovascular and metabolic disease, including elevated cholesterol and insulin levels.
Lipase inhibitors have also shown benefit for the treatment of Type II diabetes in obese patients and is the only obesity drug approved for adolescents.This has the potential to greatly enhance the market opportunity for lipase inhibitors.
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Alizyme is a speciality pharmaceutical development company, based in Cambridge, UK, targeting the treatment and management of gastrointestinal disorders, obesity and diabetes. It has a portfolio of products which, in addition to ATL-962, includes renzapride (completed Phase II for irritable bowel syndrome), COLAL-PREDÒ (completed Phase II for the treatment/maintenance of remission of ulcerative colitis), and ATL-104 (in Phase IIa for mucositis).
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