Arecor Therapeutics PLC (AIM:AREC) has received the go-ahead from US regulator the Food and Drug Administration to start clinical trials of AT247, an ultra-rapid insulin for the treatment of diabetes.
The investigational new drug (IND) clearance will enable a US Phase I clinical trial in approximately 24 participants with type I diabetes, said Arecor.
The trial will compare AT247 with Novo Nordisk (NYSE:NVO)’s NovoRapid and Fiasp, two market-leading rapid-acting insulin treatments, and also assess its potential when delivered via an insulin pump.
Sarah Howell, Areacor’s chief executive, said: "FDA clearance of the IND for AT247 marks an important milestone for this product, which has been enabled with our proprietary formulation technology platform, Arestat.
"We look forward to initiating the next clinical study, which will be our first study in the US, and has been designed to further demonstrate the superiority of AT247 compared to current market leaders.
“With c463mln people living with diabetes world-wide, of which approximately 56mln are insulin users, the management of blood glucose control remains a serious issue.“
Shares in the AIM-listed group rose by 8% to 255p.