At278 Insulin Proves Superior in Phase i Trial for Overweight Type 2 Diabetics

Arecor Therapeutics plc (AIM: AREC), a leading biopharmaceutical company, has announced that its novel insulin candidate, AT278, has demonstrated superior results in a Phase I clinical trial involving patients with Type 2 diabetes and a high body mass index (BMI). This ultra-concentrated, ultra-rapid acting insulin formulation met all primary and secondary endpoints in the study, showcasing its potential as a groundbreaking treatment in the diabetes market.

AT278, with a concentration of 500 U/mL, is designed to accelerate insulin absorption even when delivered in high concentrations, thus requiring lower injection volumes. This unique formulation positions AT278 as the first of its kind in the market, addressing the unmet needs of patients who require high daily doses of insulin.

Dr. Sarah Howell, CEO of Arecor, expressed her enthusiasm regarding the successful results of this second Phase I study. She highlighted that the trial confirmed AT278's superiority over existing insulin treatments, such as NovoRapid® and Humulin® R U-500, in patients with Type 2 diabetes and high BMI. These findings build on previous Phase I results in Type 1 diabetic patients, reinforcing AT278’s potential to offer a superior insulin treatment option that could significantly reduce the burden for patients who need high daily doses of insulin.

The clinical trial was a double-blind, randomized, two-way crossover study comparing the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of AT278 with NovoRapid® and Humulin® R U-500. Involving 39 participants with Type 2 diabetes and a BMI range of 25 to 39 kg/m2, the study revealed that AT278 not only met the primary endpoint of non-inferiority but also demonstrated a significantly faster early PK/PD profile compared to both NovoRapid® and Humulin® R U-500.

Professor Thomas Pieber, the Principal Investigator for the clinical trial, emphasized the significance of these results, noting that AT278 showcased a much faster insulin absorption rate and an accelerated PK/PD profile. This positions AT278 as a unique and superior option in the highly competitive field of insulin analogues. Notably, AT278 has the potential to improve post-prandial glucose control and reduce the treatment burden for patients with high daily insulin needs.

The importance of AT278 extends beyond individual patient benefits. This ultra-concentrated, ultra-rapid insulin formulation is a critical step towards the development of next-generation miniaturized and long-wearing insulin pumps. Such advancements are anticipated to revolutionize diabetes management by overcoming the size and usage barriers of existing insulin delivery systems.

With approximately 537 million people living with diabetes globally, and a significant portion requiring insulin for blood glucose management, the demand for more effective insulin treatments is growing. In the US, nearly 10% of insulin prescriptions in 2022 were for products with concentrations higher than 100 U/mL. Despite the benefits of insulin pumps and automated delivery systems, their usage remains limited among diabetes patients, partly due to the size and short duration of current pumps.

AT278 has the potential to address these challenges by supporting the miniaturization and extended wear of insulin pumps, thus expanding their usage across both Type 1 and Type 2 diabetes patients. The insulin pump market, valued at approximately $5.5 billion, stands to experience substantial growth with the introduction of AT278 and next-generation insulin pumps.

Arecor is now conducting a full analysis of the trial data to determine the best strategy for maximizing the value of AT278 for both shareholders and patients. Detailed results from the trial will be submitted for publication and presentation at upcoming international diabetes conferences. The company will also host a webinar to discuss the clinical results and future implications on Tuesday, 21 May at 14.30 BST.