By Colin Kellaher


Vertex Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration has placed the company's Phase 1/2 study of VX-880 in type 1 diabetes on clinical hold after the agency determined there is insufficient information to support dose escalation with the product.

The Boston drug maker said it was surprised by the FDA's action, and that it plans to work with the agency to understand and address its questions so the trial can resume at U.S. sites as soon as possible.

Vertex, which is studying VX-880 as an insulin-producing islet cell therapy in people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia, said two patients in Part A of the study received VX-880 at half the target dose, with positive data from those patients establishing proof-of-concept for VX-880.

The company said a third patient has received the full target dose with initiation of Part B of the study, adding that VX-880 has been generally well tolerated in all three patients dosed to date.

Shares of Vertex, which closed Friday at $273.33, fell 4.5%, to $261, in light premarket trading Monday.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

05-02-22 0904ET