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Diabetology has been recognized by Life Sciences Review Magazine as the exclusive recipient of “Top 5 Clinical Stage Biopharmaceutical Companies in Australia – 2023,” based on our proprietary methodology, reflecting its position in the industry. This profile has been developed by the Life Sciences Review research and editorial team based on insights from an interview with , .

Diabetology
Advancing Diabetes and Obesity Treatments through Oral Medications

Diabetology

Glen Travers, Co-founder and Dr Roger New, Co-founder, DiabetologyGlen Travers, Co-founder and Dr Roger New, Co-founder
Diabetology Limited is an award-winning clinical-stage biopharmaceutical company that solves a physician’s dilemma of improving insulin effectiveness without side effects. The company discovered the possibility of delivering insulin in the form of Capsulin Oral Anti- Diabetic (OAD), an easy-to-swallow capsule to be consumed twice daily.

The proprietary, versatile delivery system allows insulin and other proteins such as GLP-1 RAs to be ingested orally, bringing normalcy to the lives of diabetes patients.

“Our novel oral delivery system is physiologically consistent with how the pancreas and the liver naturally control the glucose levels in our bodies,” says Dr. Roger New, co-founder of Diabetology.

After extensive research, Dr. New has successfully developed a powerful capsule formulation that overcomes stomach acidity and protease attacks in the upper intestine, ultimately enhancing its availability to the body, and specifically to the liver where insulin exerts its primary activities. Capsulin OAD contains pharmacopeia-safe special excipients that activate gut cells, helping insulin to pass through the epithelium and enter the liver’s portal vein. This innovative approach significantly improves insulin delivery in a reproducible manner, lowering the risk of hypoglycemia as compared to other methods like sublingual tablets, pumps, EpiPens, and subcutaneous injections.

Recent research led by Diabetology has made significant discoveries about Capsulin OAD’s ability to solve two predominant industry-plaguing challenges—cost-effectiveness and toxicity.

Given the high cost of recombinant human insulin per dosage, direct delivery to the liver cells reduces the required medication, making it commercially viable. This eliminates the possibility of toxicity, which could accidentally occur while injecting it into the outer circulation.

“A recent phase 2b study has demonstrated that our delivery is safe with no hypoglycemia or insulinemia. As a result, there is a positive impact on fasting plasma glucose, systolic blood pressure, triglycerides and lipid levels that play a role in the body’s cardiovascular health,” says Glen Travers, co-founder of Diabetology.

In addition, the direct passage of Capsulin via the gut to the portal vein, and then to the liver, decreases insulin resistance while improving its effectiveness. This factor could enable healthcare professionals to also administer Capsulin OAD in the early stages of diabetes, owing to its range of positive effects, including the potential to preserve Beta cell function. The co-founders currently look forward to witnessing favourable outcomes from a phase 3 study of Capsulin OAD in coming clinical trials with Type 2 diabetes patients.

Our novel oral delivery system is physiologically consistent with how the pancreas and the liver naturally control the glucose levels in our bodies

Patients who took part in a phase 2a study demonstrated the body’s response to glucose disposal in a glucose clamp study, with the liver receptors quickly attaching to the hormone. The capsule minimizes the possibility of hyperinsulinemia, since the required biological effects are achieved without needing high levels of insulin in the bloodstream.

Animal trials have also confirmed the precise quantity of protein which can be delivered to the liver via the oral capsule. Besides demonstrating its effectiveness, the tests proved Capsulin OAD’s capacity to avert potential unwanted effects that may arise if the hormone is injected into the outer circulation.

Diabetology’s phase 2b study consisted of 100 patients who were administered two doses per day. After 12 weeks, the company attained key parameters that confirmed the product’s efficacy—falling HbA1c, fasting plasma glucose, systolic blood pressure and triglycerides. This trial also reported no cases of hypoglycemia.

Numerous other studies have unearthed Diabetology’s oral delivery system’s immense potential and ability to efficiently deliver other APIs such as Glucagon-like Peptide 1 (GLP 1) receptor agonists. This has led to the company developing a single capsule of GLP-1/insulin combination that has been tested in animals for oral absorption. This pioneering result was recently presented at the American Diabetes Association.

Fuelled by its breakthrough achievement, the biopharmaceutical company plans to enter into strategic relationships to develop new life-changing medications. This strategy aligns with Diabetology’s aspiration to extend beyond commercial interests and positively impact individuals who do not have access to expensive treatments.

Top 5 Clinical Stage Biopharmaceutical Companies in Australia – 2023
Current Issue

Company : Diabetology

Management
Glen Travers, Co-founder and Dr Roger New, Co-founder

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