Vertex Pharmaceuticals Incorporated (VRTX) issued updates on its phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic
islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. The Independent Data Monitoring Committee reviewed the totality of the safety and efficacy data from the first two patients dosed in part A of the study and recommended advancement to part B, where patients receive the full target dose of VX-880. The company noted that the first patient to receive the full target dose has achieved the day 29 follow-up milestone. VX-880 has been generally well tolerated to date.
Vertex Pharmaceuticals also announced the VX-880 phase 1/2 study has been placed on
clinical hold in the U.S. by the FDA due to a determination that there is insufficient information to support dose escalation with the product.
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