Vertex has announced that its Phase 1/2 trial for its VX-880 stem cell-derived islet therapy is converting to a Phase 1/2/3 pivotal trial, enrolling 50 total people. This is the first time that a scalable cure for some people with Type 1 diabetes has entered a Phase 3 clinical trial.
Cell therapies such as Vertex’s VX-880 aim to make insulin-producing cells and safely put them inside the body to replace cells that have been lost. VX-880 uses stem cell-derived islets, which primarily contain beta cells, to restore the body’s ability to produce insulin.
VX-880 is not suited for the entire T1D community: it is currently only being tested in people with T1D with severe hypoglycaemia unawareness and significant hypoglycaemic episodes. Nevertheless, the data on how this therapy is working is exciting. All of the participants who have received the full dose of the therapy are showing benefits, including: insulin production, the elimination of severe hypoglycaemia and significantly improved glucose control. Indeed, 11 out of the 12 participants have reduced or eliminated the need for external insulin.
However, a new therapy must undergo a series of clinical trials to assess its safety and efficacy before receiving FDA approval, with the last stage usually being a Phase 3, or pivotal trial, which gathers the data required for an FDA submission.
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