As we predicted last year, the diabetes market is booming, particularly after the incredible success of new diabetes drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro. There are now several diabetes biotech companies that are garnering attention, all with their own innovative solutions to tackling both type 1 and type 2 diabetes.
The prevalence of diabetes is currently on the rise, as the number of people with the disease rose from 108 million in 1980 to 422 million in 2014, according to the World Health Organization (WHO). Diabetes is also a major cause of blindness, kidney failure, heart attacks, stroke, and lower limb amputation, and, in 2019, it caused an estimated 2 million deaths.
Due to its severity, and the fact that it is considered to be an epidemic, the biotech industry is currently striving to develop new diabetes treatments. In this article, we take a look at six diabetes biotech companies looking to change the lives of patients.
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There are currently several different classes of type 2 diabetes drugs approved by the U.S. Food and Drug Administration (FDA), which can lose their effectiveness over time, with most of them involving modulation of insulin production and sensitivity.
But Swedish company Atrogi is seeking a better treatment solution for type 2 diabetes, which it says has the advantage of a unique pathway that does not target the insulin pathway. Instead, the company’s small molecules promote increased glucose uptake into skeletal muscles independent of insulin, and can be modulated to activate their target with minimal side effects.
In January 2023, the diabetes biotech company announced that the first patient had been enrolled in a phase 1a/b study for its drug candidate ATR-258, which is a first-in-class novel b2 adrenoceptor agonist with a unique mechanism of action for the treatment of type 2 diabetes and comorbidities. It is intended to lower blood glucose to healthy levels independent of insulin, enhance insulin sensitivity, and lower insulin production. The treatment can potentially function as a stand-alone or a combination therapy.
While most companies developing menin inhibitors are developing them solely as cancer therapies, Biomea Fusion – which looks to treat both cancer itself, and drivers of cancer – is going down a different route, developing a menin inhibitor not just for cancers, but also for type 1 and type 2 diabetes.
This is because menin is thought to act as a brake on beta cell turnover – or beta cell growth – supporting the notion that inhibition of menin could lead to the regeneration of normal healthy beta cells – which are found in the pancreas and are responsible for the synthesis and secretion of insulin. In patients with diabetes, beta cell mass and function are diminished, leading to insufficient insulin secretion and hyperglycemia.
In March, Biomea announced positive data regarding its phase 2 study of its lead drug candidate – known as BMF-219 – in patients with type 2 diabetes. The company released results from two groups of patients whose type 2 diabetes was poorly controlled despite using available medications. Trial participants who took the drug on an empty stomach showed an 89% response rate, with 56% achieving a reduction of at least 1% in a blood sugar measurement known as A1C, which was significant, as the company had previously said that a reduction of around 0.3% would be considered a positive result.
And, more recently, in October, Biomea also announced that the FDA had cleared its investigational new drug (IND) application to study BMF-219 in adults with type 1 diabetes.
Diabetes biotech company DiogenX is focused on discovering and developing innovative therapies for diabetic patients around the world. Its lead program aims to regenerate pancreatic insulin-producing beta cells using a recombinant protein, which modulates the Wnt/β-catenin signaling pathway, which is a highly conserved pathway, normally acting during embryonic development and in regenerating tissues. By modulating this pathway in beta cells, the company’s drug candidate induces their replication.
DiogenX says it has already demonstrated efficacy in preventing and reversing diabetes using in vivo models of type 1 diabetes, and achieved a first proof of principle with a significant increase in functional insulin-producing human beta cells in preclinical experiments. Long-term exposure was well tolerated in preclinical studies, supporting the ability to safely intervene on the Wnt/β-catenin pathway with DiogenX’s approach.
In May 2023, the company managed to raise €27.5 million ($30 million) in a series A financing round. The proceeds from this are being used to advance its lead drug candidate toward clinical development.
Fractyl Health is working on developing a gene therapy alternative to drugs like Ozempic and Wegovy to control both blood sugar and body weight without repeated injections. The idea behind this is that a gene therapy treatment would only need to be given to patients once, as a single shot, which avoids the issue of patients stopping or forgetting to take their medication.
To achieve its goal, the company wants to deliver an artificial gene to the pancreas that continuously produces the GLP-1 hormone. In order to deliver the therapy to the pancreas, Fractyl has developed an endoscopic procedure that involves threading a thin needle attached to a catheter that travels down the throat and into the GI tract.
The diabetes biotech company has so far tested its gene therapy approach in animals. Scientists at the company wanted to see how well the experimental gene therapy could reduce fasting blood sugar. Using mice bred to develop type 2 diabetes, they gave a single infusion of the therapy to one group, and weekly injections of semaglutide to another. After 10 weeks, they found that the gene therapy decreased fasting blood sugar by 70 percent, which was actually slightly more than semaglutide.
Glyscend Therapeutics is looking to develop a new generation of orally administered first-in-class gut-targeted polymer therapies. The biotech company’s lead candidate is called GLY-200, for the treatment of both type 2 diabetes and obesity.
GLY-200 is being developed to modulate the mucosal barrier in the GI tract and achieve the therapeutic benefits of gastric bypass – which has immediate and profound effects on improving blood glucose while reducing body weight and reducing long-term micro- and macro-vascular complications related to type 2 diabetes – without the need for an invasive procedure. It is designed to interact with the mucus membrane in the duodenum to form a dynamic barrier to prevent interaction between the food and the mucosal surface of the duodenum. The candidate is currently in an ongoing phase 2 study.
In July, it was also announced that data across the completed phase 1 and 2a trials demonstrated that the novel mechanism of GLY-200 offers significant and clinically relevant reductions in postprandial glucose and body weight, supporting its advancement into a phase 2b trial.
Imcyse is a clinical-stage biopharmaceutical company committed to advancing the development of a new class of specific immunotherapies. Its technology platform produces synthetic peptides that are based on naturally occurring proteins, known as Imotopes, which use the patient’s own immune system to break abnormal immune responses, thereby recalibrating the immune system.
The biotech company’s lead candidate is called IMCY-0098, and is for the treatment of type 1 diabetes. The candidate is a synthetic peptide based on insulin, and is designed to halt the progression of diabetes by stopping the body’s immune system from attacking beta cells. With early intervention, the pancreas’ ability to produce insulin may be preserved, enabling patients to manage the disease with minimal insulin injections and, hopefully, in some cases, without the need for insulin at all.
Earlier this year, the company announced the completion of patient enrollment in a phase 2 trial of IMCY-0098, where it exceeded target enrollment with 110 patients randomized across 28 clinical sites in Europe, the U.S., and Australia.
Global diabetes drug market size expected to grow further
According to research conducted by Precedence, the global diabetes drug market size was estimated at $61.87 billion in 2022, and is projected to hit around $118 billion by 2032, growing at a compound annual growth rate (CAGR) of 6.67% during the forecast period 2023 to 2032.
With this in mind, the diabetes market is likely to grow even more crowded, and, just within the last few months, we have already seen the demand for diabetes and obesity drugs begin to skyrocket.
This will inevitably lead to more and more biotech companies looking to make their name developing innovative – and more effective – approaches to tackling diabetes.