Vertex Pharmaceuticals Incorporated (VRTX) announced the FDA has cleared the Investigational New Drug Application for VX-264, a stem cell-derived, fully differentiated pancreatic islet cell therapy encapsulated into a Vertex-developed, immunoprotective device with the potential to treat type 1 diabetes.
The company plans to initiate a Phase 1/2 clinical trial in the first half of 2023 to study the safety, tolerability and efficacy of VX-264 in patients with type 1 diabetes.
Bastiano Sanna, EVP and Chief of Cell and Genetic Therapies at Vertex, said: "We are excited to see our second program in T1D advancing into the clinic and look forward to bringing transformative, if not curative, therapies to T1D patients who are waiting."
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