As 2024 unfolds, the biotechnology industry is brimming with potential, spearheading scientific innovation. This year is particularly exciting as a diverse range of biotech companies are poised to break new ground to tackle global challenges. Two areas of growing concern are:
Diabetes which is currently on the rise, is of major concern as it is also a major cause of blindness, kidney failure, heart attacks, stroke, and lower limb amputation.
The second area of concern is obesity which is a global escalating source of type 2 diabetes leading to the previously mentioned morbidities and straining our health systems.
Diabetology Limited is an award-winning clinical-stage biopharmaceutical company. It employs a proprietary targeting oral delivery system to administer known macromolecule drugs as well as novel combinations to transform the treatment outcomes for patients with diabetes and/or obesity. The Lifesciences Magazine is proud to feature Diabetology under the issue ‘The Most Innovative Biopharma Company Targeting Diabetes – 2024’
Improving Quality of Life
Diabetology Limited specializes in targeted oral drug delivery in metabolic diseases such as diabetes and obesity. The company is committed to improving the quality of life for patients with diabetes. The disease now affects up to 10% of the population in many different ways, and its proprietary technologies, enabling ingestion of insulin and other protein drugs like GLP1 RA via the oral route, could bring back normality to the lives of diabetes sufferers. Oral insulin is not only more convenient for the patient but avoids certain complications of the disease without introducing new side effects, improving the patient’s general health and well-being.
Diabetology Limited helps diabetic patients by shaping their future for a better tomorrow. One of the biggest burdens to society is the reaction some people have to certain foods and beverages that lead to inflammatory conditions that can result in insulin resistance, diabetes, obesity, cardiovascular disease, blindness, neuropathies, renal dysfunction, and dementia. 42% of US adults are now obese. The cost of related health issues is a drain on the healthcare provision of most nations. However, diabetes and obesity are not just a Western problem, it is a universal one. Targeted formulation technology can make the process of development of solutions safer, more effective, and efficient. Formulation algorithms have been used to identify non-NCE excipients that can safely enhance the function of proteins and peptides delivered directly to key sights of action to impact disease.
Capsulin Oral Anti-Diabetic (OAD) Initially for Type 2 Diabetes
Diabetology Limited 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 for type 2 diabetes. The proprietary, targeted delivery system allows insulin and other proteins such as GLP-1 RAs to be ingested orally, bringing more 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 Limited.
After extensive research, Dr. New has successfully developed a powerful capsule formulation that overcomes stomach acidity and protease attacks in the upper intestine. The capsule ultimately enhances its availability to the body by being absorbed transcellularly, 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 without the need for titration, lowering the risk of hypoglycemia as compared to methods like sublingual tablets, pumps, EpiPens, and subcutaneous injections that deliver high insulin levels directly to the outer circulation.
Dynamic Professional Experience
Alongside Dr. New, Glen Travers (Co-founder of Diabetology Limited) is spearheading the growth of Diabetology. Skilled in Medical Devices, Oral Vaccines, and Biotechnology company development, Glen has a bright history of working in the biotechnology industry. He is a strong entrepreneurship professional focused on bringing important products to market as well as having a background in corporate finance. He has been on the international board representing 1000 European CEO’s as a member of US headquartered Young Presidents Organisation which is a global gathering of CEO Peers. YPO runs many courses and activities from leadership, management, health technology, AI to self-learning and holistic well-being.
Glen started his professional journey with the Development Capital company in Western Australia and listed it creating a $700m market capitalization. Diabetology Limited started investing in a range of industries including Engineering, Fashion Retail, Leverage Buyouts ($1bn Beatrice international Group buyout), Pharmaceuticals, Lifescience R&D (co-royalty holders with Nobel Laureates for a breakthrough in helicobacter and developed the first oral COPD vaccine called Broncostat sold to large pharma). Thereafter, it was converted to pure biotech play with oral drug delivery platforms, POC diagnostics, and Branded Pharmaceuticals in the UK.
A Purpose Beyond Financial Gain
Following his earlier successes, Glen established the Travers Family Office to pursue their metabolic ambitions. This task has been led by his Diabetology Limited co-founder Dr. Roger New and ably supported by his family consisting of two medical doctors, one Dr of Clinical Psychology specializing in eating disorders, and, one Cambridge University graduate majoring in natural sciences all of whom have been incredibly supportive.
For his astute leadership skills, Glen has been bestowed with numerous awards and accolades throughout his journey. He was awarded E&Y Healthcare Entrepreneur in the EU, and his company was awarded as the best-performing company listed on ASX over 3 years (peak mkt cap >$1bn). The company launched products for blood pressure, gallstones, an oral vaccine for COPD (and sold to Rhone Poulenc Rorer), launched the first POC diagnostic for bacterial infection (Helisal – licensed to Boehringer Mannheim, Astra, Becton Dickinson amongst others), the first evidence of oral insulin at Oxford Radcliffe hospital in type 1 diabetics and other projects.
Glen’s family office aimed to impact the biotech industry with the need to do more than earn money. His best friend’s father had a type 1 diabetes journey of deafness, and amputations and he recognized the potential burden to society of metabolic diseases. The incident inspired him to make efforts and bring innovation to the industry. Finding financial support for an expensive industry and support for breakthrough thoughts and projects were the biggest challenges in terms of initially rising through the ranks.
Collaborative, Open Geographically Agnostic Approach towards Leading
By minimizing administrative costs through virtual meetings, being agnostic to geography, and maximizing knowledge opportunities, Glen makes sure that his leadership philosophy is reflected in his team. Whenever possible, he outsources to leaders in their fields and relies on their own inspiration and desire to achieve meaningful goals in life. He suggests upcoming leaders be well educated in their relevant activity, consider undertaking Master’s in Biotech courses to pursue lifescience startups and work with innovators to make a difference to patients. Allowing 2-sided thinking is very helpful to avoid missing important ideas and this helps to be flexible in discussions and work relationships.
Glen’s Leadership Philosophy includes:
Mitigating the Risk of Side Effects and Hypoglycemia – using Natural Pathways
Recent research led by Diabetology Limited has made significant discoveries about Capsulin OAD’s ability to solve two predominant industry challenges—cost-effectiveness and reduction of side effects. Given the cost of recombinant human insulin per dosage, Capsulin oral insulin, transported via the gut into the portal vein directly to the liver cells, reduces the cost of the required medication, making it commercially viable, and eliminates the possibility of hypoglycemia, which can accidentally occur while injecting non-physiological levels of insulin into the outer circulation.
“A recent phase 2b study has demonstrated that our Capsulin product 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 with no weight gain that also play a role in the body’s cardiovascular health,” adds Glen.
The biopharmaceutical industry has vast scope to grow and one way to view this is to look at what proportion of a nation’s GDP is consumed by the issues around healthcare which is now rising to 20% in the US. Following the COVID crisis, health institutions are becoming stronger despite some of them, including academic research organizations, facing national funding issues that need to be addressed. The most predominant issues include independently evaluating and supporting R&D in life science, to streamline the development costs and improve the effectiveness of treatments for the aging demographics in key economies, and, for some rapidly growing resource-constrained populations. Food companies need to be included in these considerations. It is important for us to stay alert and be prepared for any next health crisis. Information is available that can provide advance warnings of potential health crises ahead including e.g. antibiotic resistance and further outbreaks of pandemic disease. A current crisis though in ever heavier debt-laden economies, is the need to provide support for the many research opportunities that are not funded or must wait for a crisis to emerge before there is rushed investment and support. This can result in less effective human health responses to predictable issues.
An Era ahead of AI combined with Supercomputing: Allowing Faster, Lower Cost Advancement for Disease Solutions
AI and supercomputing usage assists many areas of disease understanding, diagnosis, and drug development. This creates efficiencies to advance the latest technologies in the industry promising exponential opportunity for improvement in human health. According to Glen, the resultant cell function, genetic, DNA, RNA, epigenetics, microbiome, and neuroceuticals treatment, diagnostic, and preventive developments evolving from research universities and the biopharma industry will lead to better health outcomes. These efficiencies could even assist the challenge of reaching those who cannot afford them. It is important to share in the benefits of great innovations beyond the country of origin. The healthcare industry is making promising advances with these new technologies from which hopefully all can benefit.
In Diabetology Limited, their technological advancement allows direct passage of Capsulin via the gut to the portal vein, and then to the liver, which returns glucose control to the liver. This has the potential to decrease insulin resistance while improving its effectiveness of glucose control. This ability could enable healthcare professionals to administer Capsulin OAD in the early stages of diabetes, owing to its range of positive effects, including the potential to preserve Beta cell function potentially restoring exhausted islet cell insulin production. The co-founders currently look forward to witnessing favorable outcomes from a phase 3 study of Capsulin OAD in coming clinical trials with Type 2 diabetes patients.
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 and allowing the liver to regulate glucose levels in spite of the patient’s insulin resistance. The capsule minimizes the possibility of hyperinsulinemia since the required biological effects are achieved without needing high levels of insulin in the bloodstream.
Capsulin oral insulin Peer-Reviewed Publication of Phase 2b clinical study safe and effective; Preparing for FDA Phase 3
Much earlier animal trials have also confirmed the optimal quantity of protein that 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, Diabetology Limited attained key parameters that confirmed the product’s efficacy—falling HbA1c, fasting plasma glucose, systolic blood pressure, and triglycerides. This peer-reviewed and published trial also reported no cases of hypoglycemia even when the dose of insulin used was doubled confirming the benefit of the targeted pathway showing liver glucose control from twice daily fixed dosing without the need for titration of insulin levels.
An Oral Once Daily or Weekly Neuroceutical to stimulate the Vagus Nerve Satiety Response to Treat Obesity?
Numerous other studies have unearthed Diabetology Limited’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 daily dose capsule of a GLP1 RA as well as a GLP-1/insulin combination that has successfully been tested in animals for oral absorption. This pioneering result for diabetes was recently presented at the American Diabetes Association. The company is also utilizing its targeting formulation oral capsule delivery system to direct GLP1 RA’s to the gut where the L cells produce natural GLP1. This is where the omnipotent Vagus Nerve has GLP1 receptors to signal directly the satiety centers of the brain which in turn signals organs such as the pancreas, stomach, and liver to increase insulin release, improve glucose balance, and trigger food satiety responses in the brain and stomach. This unique neuroceutical benefit seen in small and large animal tests is demonstrating that a once-daily and potentially once weekly oral dosing of certain GLP1RA’s is probable. These predictive studies have shown comparatively very high oral biopotency with very low blood levels opening up the potential for reduced side effects such as nausea and vomiting due to reduced drug load in the outer circulation and is entering the clinic shortly with the potential for treating obesity.
Fuelled by its breakthrough achievements from its Travers Family Office beginnings, Diabetology Limited plans to enter into strategic relationships to develop new life-changing medications. This strategy aligns with the company’s aspiration to extend beyond commercial interests and positively impact disadvantaged individuals and even countries who do not have access to life-changing treatments.
“Our novel receptor targeting oral delivery system is physiologically consistent with how the pancreas and liver naturally control glucose disposal in our bodies.”
