19th October, 2005

New Hope for Diabetes Sufferers with Insulin Pills

Diabetology Ltd, the biopharmaceutical company based in Jersey, UK, with a laboratory in London, has announced that oral insulin, Capsulin™, has successfully completed proof of concept phase 2a studies. These show that a preparation of insulin which can be taken in capsule form is absorbed and has a measurable effect on plasma insulin concentrations in diabetics who have to inject insulin.

The phase 2a results of clinical trials of Capsulin carried out at Bradford Teaching Hospital were presented in June of this year at the American Diabetes Association (ADA) annual meeting in San Diego. This followed presentation of results of an earlier phase 1 study last year at the ADA meeting in Philadelphia.

These results have been welcomed by American and UK diabetes specialists as giving new hope of more effective treatment without injections for millions of diabetes sufferers worldwide.

Dr Roger New, the co-founder of Diabetology Ltd, explained the importance of the new oral peptide treatment:-

"We have worked for many years to provide an effective treatment for patients to take insulin capsules instead of injections. We have developed a preparation of insulin which can be ingested orally and absorbed to have measurable effect on plasma insulin concentrations. One of the key hurdles has been to achieve a level of absorption that would make the pill affordable. Our approach offers the potential for effective therapeutic use of Capsulin oral insulin in diabetes and may be a more physiological, and therefore preferable, means of delivering insulin. Further studies are required to assess the full clinical potential of Capsulin oral insulin in both type 1 and type 2 diabetes".

"At the San Diego meeting of the American Diabetes Association in June 2005, I and my colleagues Professor Whitelaw, Christine Kelly, Wendy Ironmonger from the Department of Diabetes and Endocrinology at Bradford Teaching Hospital, Clare Cunliffe and Gurpal Bansal, presented our findings that showed that the Capsulin oral insulin formulation is active in type 1 diabetics who have to inject insulin to stay alive as their body does not produce it".

Commenting on this development, Professor Donald Whitelaw, Consultant Physician in Diabetes & Endocrinology, Bradford Teaching Hospitals NHS Trust, said:-

"The opportunity to have insulin available in oral (capsule or tablet) form has been a goal for researchers and people with diabetes for many years. This study has shown that Capsulin, studied for the first time in people with type 1 (insulin dependent) diabetes, produces an increase in plasma insulin while maintaining or even lowering blood glucose. Capsulin therefore provides a means of delivering insulin via the gut in a form which is acceptable and easy to take. Further studies will establish its suitability for use in everyday medical practice."

Diabetology are now embarking on further studies to assess the full clinical potential of Capsulin oral insulin for both type 1 and type 2 diabetes.

It is anticipated that within three years insulin in capsule form could be available for patient treatment if the further trials are successful. This is likely to have a major impact on treatment particulary for the 10 million old and young people with diabetes whom the NHS will have to treat by 2010.