Arecor Therapeutics PLC (AIM:AREC)'s chief executive Sarah Howell said the company is at an advanced stage of recruiting patients for phase one trials of rapid ultra-concentrated insulin and should be ready to announce the results at the end of the first quarter of 2024.
The new and ultra-concentrated formulation developed by Arecor has been designed to accelerate the absorption of insulin, a hormone made by the pancreas, after injection.
This is just one of a growing suite of advanced pharmaceutical technology in its Arestat portfolio, which can add value to existing drugs by enhancing the concentration and speed at which they are administered.
This portfolio has the potential to reduce the burden on hospitals by speeding up the time it takes to administer, in some cases life-saving drugs, often by focusing on delivery methods, and offering ready-mixed, rapid-acting and ultra-concentrated alternatives.
Rapid-acting insulin
Rapid-acting insulin AT278 is designed to help diabetes patients who have to take regular high doses of insulin to manage their blood glucose levels.
The biotechnology company’s highly concentrated rapid-acting insulin could help patients dramatically reduce the number of times a day they must inject the drug, and could one day enable the delivery of insulin through wearable miniature patch pumps.
With one in ten adults now affected with diabetes, and 56 million people injecting themselves with insulin every day, the global insulin market has reached US$22 billion.
“It’s a huge and growing problem as 537 million people now are living with diabetes worldwide,” Howell said in an exclusive interview with Proactiveinvestors, adding that the market for meal-time insulin now stands at over US$6 billion.
“We are focused on insulins and in particular insulins that are taken to control blood glucose around meal times.”
Howell revealed during the interview that she was wearing a glucose monitor on her arm for research purposes to better understand how blood glucose spikes after meals.
Since 70% of diabetes patients die from cardiovascular disease, fast-acting insulin that can keep glucose levels in a safe range is crucial.
“Many people with diabetes are still not well controlled on existing therapy, so there's a real need there,” Howell explained, adding that the recruitment process for the clinical trial is going ‘really well’.
“We'd be expecting to read out headline results on that, to the end of quarter one next year, so quite soon.”
The problem that pharma groups have run into when attempting to develop concentrated insulin in the past, is that it becomes slower acting, so “there are no highly concentrated rapid-acting insulins” on the market now, Howell said.
Arecor’s AT278 rapid-acting insulin “is the only insulin in development that has been able to achieve this profile”, she added.
The progress Arecor has made is significant because it could one day facilitate the development of continuous pumps worn for a week or longer, which would eliminate the need for extra injections alongside meals.
“There’s an unmet need there,” said Howell.
The next leap in development, she said, would be in the development of faster-acting insulins, such as Arecor's AT247, which would allow the potential for an ‘artificial pancreas’ for diabetes patients.
Arecor is engaged in perennial, ongoing discussions to develop further products in the insulin space, according to Howell.
Whereas it would take standalone developments up to 20 years to get to market, Arecor uses patented formulations of existing and proven therapeutics to enhance speed and delivery, and Howell estimates these products could be on the market three years from now.
Insulin drugs and the weight-loss boom
The market for diabetes drugs is expected to grow even further, as pharmaceutical companies tap into the market for weight-loss drugs.
Major pharma groups such as Novo Nordisk (NYSE:NVO) are rolling out glucagon-like peptide 1 (GLP-1) drugs, which stimulate the body to produce insulin, in droves, stirring up a flurry of excitement among shareholders.
Novo Nordisk (NYSE:NVO) wiped more than US$5 billion from the share prices of the three main kidney dialysis operators in October after its clinical trial showed that GLP-1 drug Ozempic, which doubles as a weight-loss aid, was successful in treating patients.
Semaglutide Wegovy has been available on the NHS as an option for weight management since September, according to the government website.
“GLP 1 is another area that can be used in conjunction with insulin in obese patients. They’re complementary to the products that we’re developing,” Howell said.
She identified areas to improve better versions of GLP 1, indicating that other forms of delivery such as oral could be key.
Hospital setting
A critical and urgent application of Arecor’s Arestat portfolio involves developing faster-acting and easier-to-use, ready-mixed, products for hospitals that avoid complex reconstitution processes.
In chronic and emergency care when life-saving drugs are only available in a powder that has to be mixed to the right ratio for an intravenous (IV) infusion bag, which can lead to errors, Arecor is developing safer and quicker alternatives that can be used as a ready-mixed product.
The development pathway of such drugs is “fast”, said Howell, because Arecor’s technology enhances these medicines “using approved excipients”.
Where Arecor can add value is by enhancing the concentration and speed at which existing drugs are administered, due to its technology platform.
Oncology is another area where “you want to be able to reduce the chair time” of chemotherapy drugs such as methotrexate that are administered in an IV, said Howell.
“We’re… agnostic to the therapeutic area,” she said, adding that the idea behind the Arestat portfolio of rapid-acting, ultra-concentrated and easier-to-use medicine enhancers is to help reduce the burden on hospitals, caregivers and patients.
“We’re removing safety issues and actually, removing the time burden, so actually, reducing costs for the healthcare system as well,” Howell said.