25 June 2021
INSULIN CAPSULES OFFER NEW HOPE FOR PEOPLE WITH DIABETES
Diabetology Ltd, a British company with activities in UK and Australia, has announced that its oral insulin, (Capsulin™), has successfully completed 25,000 dosing events in a phase 2b study in early stage type 2 diabetes patients.
The phase 2b study, being presented as late breaking news at the forthcoming American Diabetes Association meeting, shows that the capsule formulation can achieve statistically significant changes in key parameters. The target dose of just 150iu (5mg) per capsule can bring the primary endpoint of the study - HbA1c (glycated haemoglobin), secondary endpoint - FPG (fasting blood glucose) and triglycerides back down towards recommended ranges within just 12 weeks of treatment, with no accompanying weight gain. The trial met its endpoint in patients with early-stage diabetes of a fall in HbA1c >0.5%. The data also showed that the higher the entry level of HbA1c, the higher the Capsulin response achieved, culminating in a statistically significant fall greater than a mean of 1.3% (p = 0.035) for those patients entering with an HbA1c of >9% in the combined 150 and 300IU dose groups.
An important aspect of the study is that there were no incidences of hypoglycaemia in the 12 week treatment period, even at double the target dose, as was anticipated. This is due to the absorption of the insulin from the small intestine into the portal vein system which directs insulin to the liver where glucose control is regulated, but avoids high levels of insulin going into the peripheral bloodstream. The concept of insulin being administered without patients overdosing and putting themselves at is a much-needed breakthrough in treatment and could allow all diabetes patients to use a human insulin at any stage of the disease.
Patients exhibited dyslipidaemia when entering the study. However, both triglycerides and LDL cholesterol were lowered after being treated with 150iu insulin BID, indicating that Capsulin™ may lower the risk of cardiovascular disease.
The convenient-to-swallow capsule formulation is stable at room temperature, and contains no new chemical entities, making it a product which is very safe and easy to manufacture cost effectively on a large scale.
The phase 2b results of clinical trial of Capsulin carried out over 15 sites in India by the Clinical Research Organisation JSS Research are being presented today as late breaking news at the American Diabetes Association (ADA) annual meeting in the USA being held virtually due to the pandemic. This follows a ground-breaking UK phase 2a study in later stage type 2 diabetic patients, peer reviewed and published in the journal Diabetes, Obesity and Metabolism. Previous presentations have been made to the EASD in Rome and ADA in San Diego, describing results of an earlier phase 2 study in type 1 patients.
These results have been welcomed by diabetes specialists as giving new hope of more effective treatment for millions of diabetes sufferers worldwide.
Commenting on the news, Dr Mark Evans, Reader in Diabetic Medicine in the Institute of Metabolic Science in the University of Cambridge and Honorary Consultant Physician in Diabetes in Addenbrookes (Cambridge University Hospitals NHS Trust) said:-
“The potential for insulin to be available in an oral capsule form has been a goal for researchers and people with diabetes for many decades. This phase 2b study is promising, showing that an oral insulin preparation, Capsulin, can produce clinically-meaningful blood glucose lowering effects in people with early stage type 2 diabetes. It is particularly encouraging that this was achieved without problematic hypoglycaemia. As well as the advantage of being an oral capsule, Capsulin has the benefit of being stable at room temperature for at least 6 months which could allow widespread distribution and clinical use. All of us look forward to seeing the results of the planned larger phase 3 studies.”
Dr Roger New, the Co-Founder of Diabetology Ltd, a company within the Proxima Concepts Group, explained the importance of the new oral peptide treatment:-
“We have worked for many years to create an effective preparation of insulin for patients to take in capsule form, which can be ingested orally and absorbed to have a measurable effect on disease outcomes.
“One of the key hurdles has been to achieve a level of absorption that would make the pill affordable and safe. 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 with high margins of safety. Diabetology Ltd will be seeking approval to enter the final stage of testing in phase 3 studies. It is also embarking on further studies in Australia to assess the full clinical potential of Capsulin oral insulin for type 1 diabetes.”
The company is preparing further studies which could be pivotal for regulatory approval for Capsulin to be made available to diabetics. A successful outcome of these studies and approval for sale is likely to have a major impact on treatment particularly for the 4.7 million old and young people with diabetes in UK, who incur a health expenditure of £10 billion.
In a separate announcement the company completed an important animal study at Synovo in Germany showing that its oral delivery system shows very good potency for the oral delivery of exendin – a GLP1 receptor agonist currently used for the treatment of diabetes as an injectable. The study, also reported today at the US virtual ADA meeting, included an arm demonstrating delivery of an oral insulin/exendin combination formulation.
Glen Travers the company’s Australian-born co-founder commented “This work paves the way for ‘first in man studies’ to be carried out in Australia to develop the second available oral GLP1 for type 2 diabetes patients which also has beneficial weight control effects and potentially the first oral insulin/GLP1 RA product in a single capsule.”
Authors of the phase 2b Study
Roger New, Michal Bogus, Glen Travers, Diabetology, Ltd., London, Gajanan Namjoshi, exUSV DRG, Mumbai, India
Diabetes and Obesity*
1. There are estimated to be 4.7 million people (7% of population) with diabetes UK, many of whom are still undiagnosed. This figure is projected to rise to 5.5 million by 2030..
2. 90% of patients with diabetes are type 2 diabetics, with the remainder suffering from type 1 diabetes, gestational or other diabetes
3. 40,000 children in UK have diabetes, and 3000 new cases are diagnosed every year.
4. Around 40% of people with diabetes have diminished psychological well-being.
5. One third of patients with type 2 diabetes have a microvascular complication at the time of diagnosis.
6. Every week, diabetes is responsible for 530 myocardial infarctions and 175 amputations.
7. The NHS spends at least £10 billion a year on diabetes – 10% of its budget. 80% of this is spent on complications of the disease.
8. One in six hospital inpatients has diabetes.
9. 500 people with diabetes die prematurely every week.
10. There is a seven times greater risk of diabetes in obese people compared to those of healthy weight, with a threefold increase in risk for overweight people
11. Approximately 25% of patients with type 2 diabetes use insulin as a treatment.
1. Diabetology Ltd, a member of the Proxima Concepts Group, was established by Dr Roger New and Glen Travers in 2000.
2. The Diabetology team has many years of experience in the biopharmaceutical field and in developing solutions to diabetes.
3. A summary poster of the study is attached.
4. See also Diabetology website: www.diabetology.co.uk
For further information contact:
Dr. Roger New, Co founder and CSO, Diabetology Ltd +44 (0) 781 806 8012
Glen Travers, Co-founder, Diabetology Ltd, +44 (0) 203 2395277