Arecor Therapeutics PLC (AIM:AREC) told investors it has received positive guidance from the US Food and Drug Administration on its planned Phase 2 clinical study for AT278, an ultra-concentrated and ultra-rapid insulin candidate.
The trial will assess AT278 delivered via an Automated Insulin Delivery system in people with type 1 and type 2 diabetes. It will compare AT278 with NovoLog in fewer than 100 participants in the US
The FDA endorsed the use of “time-in-range” as the primary efficacy endpoint, allowing data to be generated in six weeks compared with a minimum of twelve weeks for traditional HbA1c measures, the company noted.
"We are aiming to establish a new frontier for the treatment of diabetes, and to bring more accessible next-generation treatment options that simplify care and improve outcomes for people living with diabetes," chief executive Sarah Howell said.
She added: "Such positive and constructive feedback from the FDA for our first-of-a-kind insulin and AID system combination study represents a significant milestone in our drug development program.
"We believe we will generate crucial data towards demonstrating the economic value of AT278 in combination with an innovative AID system."
It also intends to submit an investigational new drug application in 2026.