Arecor Therapeutics Investigational New Drug Application Cleared by FDA, Phase 1 Trial Set

By Joe Hoppe

Arecor Therapeutics PLC said Thursday that the U.S. Food and Drug Administration has cleared its investigational new drug, or IND, application for AT247, its proprietary rapid insulin treatment for diabetes.

The London-listed biopharmaceutical company--backed by Unilever PLC--said the application supports a Phase 1 clinical trial in the U.S. in around 24 participants with type 1 diabetes. The trial will be a double blind, randomized, threeway crossover study, comparing AT247 with two other market-leading insulin treatments, NovoRapid and Fiasp.

The aim of the drug is to accelerate insulin absorption, post-injection, to enable more effective management of blood glucose levels for people living with diabetes, and it has the potential to significantly improve post-prandial glucose control--avoiding both hypo-and hyperglycemic episodes.

Data from a European Phase 1 clinical study showed the drug exhibited earlier insulin appearance, exposure and offset, with an earlier glucose-lowering effect than NovoRapid and Fiasp. The data also suggests the drug can also facilitate a fully closed loop artificial pancreas, a potentially life changing treatment option.

Shares at 0722 GMT were up 16.0 pence, or 6.8%, at 252.0 pence.

Write to Joe Hoppe at [e-mail]

(END) Dow Jones Newswires

September 09, 2021 03:42 ET (07:42 GMT)

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