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[Type 1 diabetes concept suggested by insulin syringe] adrian825 Vertex Pharmaceuticals (NASDAQ:VRTX [https://seekingalpha.com/symbol/VRTX]) has posted new data from a Phase 1/2/3 study for zimislecel (VX-880), its experimental therapy for type 1 diabetes, noting that the cell-based therapy achieved the main goal in trial subjects with at least one year of follow-up. [https://seekingalpha.com/pr/20143379-vertex-presents-positive-data-for-zimislecel-in-type-1-diabetes-at-the-american-diabetes] The Boston, Massachusetts-based biotech disclosed the results on Friday at the ongoing American Diabetes Association (ADA) annual conference in Chicago as part of an oral presentation. The FORWARD-101 clinical trial was designed to evaluate the one-time infusion in T1D patients with impaired hypoglycemic awareness and severe hypoglycemic events. Citing data from 12 patients who had at least one year of follow-up in Phase 1/2 portion of the trial, the company said that all of them achieved the primary endpoint related to the elimination of severe hypoglycemic events with at least a 7% reduction in the diabetes biomarker HbA1c. While two patients died with no connection to the experimental therapy as previously reported, Vertex (NASDAQ:VRTX [https://seekingalpha.com/symbol/VRTX]) indicated an encouraging safety profile for the drug, noting that most adverse events were mild or moderate and there were no serious adverse events.
“The magnitude, consistency, and durability of the results from all 12 patients with more than one year of follow-up reinforce the transformative potential of zimislecel for people living with T1D complicated by severe hypoglycemia,” said VRTX’s medical chief, Carmen Bozic. The company said it has completed enrollments and dosing in the study while plans are underway to submit regulatory filings next year. [https://seekingalpha.com/pr/20143379-vertex-presents-positive-data-for-zimislecel-in-type-1-diabetes-at-the-american-diabetes] MORE ON VERTEX PHARMACEUTICALS * Vertex Pharmaceuticals Incorporated (VRTX) Presents at Goldman Sachs 46th Annual Global Healthcare Conference Transcript [https://seekingalpha.com/article/4793871-vertex-pharmaceuticals-incorporated-vrtx-presents-at-goldman-sachs-46th-annual-global] * Targeting The NaV1.8 Pathway In Pain Management: Eli Lilly And Vertex Lead The Way [https://seekingalpha.com/article/4791649-targeting-the-nav1-8-pathway-in-pain-management-eli-lilly-and-vertex-lead-the-way] * Vertex Pharmaceuticals Incorporated (VRTX) Bernstein 41st Annual Strategic Decisions Conference (Transcript) [https://seekingalpha.com/article/4791244-vertex-pharmaceuticals-incorporated-vrtx-bernstein-41st-annual-strategic-decisions-conference] * FDA's Prasad becoming agency's chief medical and scientific officer [https://seekingalpha.com/news/4459862-fda-prasad-becoming-agency-chief-medical-and-scientific-officer] * FDA's Makary talks up modernizing agency to get drugs to market faster [https://seekingalpha.com/news/4459149-fdas-makary-talks-up-modernizing-agency-get-drugs-market-faster]
Vertex posts additional trial data for type 1 diabetes therapy
June 21, 2025 10:35 PM AEST | By EODHD
