November 4, 2024

An announcement today by Vertex demonstrates progress on the path to type 1 diabetes (T1D) cures with the conversion of their current clinical trial for VX-880 to include phase 3. The pivotal trial will evaluate the safety and efficacy of the therapy.  

“Breakthrough T1D is thrilled that Vertex has committed to the first pivotal trial for a stem-cell derived therapy that moves us closer to T1D cures than ever before,” said Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D. “Cell therapies are one of Breakthrough T1D’s priorities, and this therapy is a key benchmark on the roadmap to cures for the entire T1D population. We congratulate Vertex on this important milestone.”  

The announcement of this trial builds on the previous success of the FORWARD phase 1/2 trial, which has been very encouraging with all participants showing benefits. To date, 11 out of 12 of those who have received the full dose of cells are insulin independent or have significantly reduced insulin needs, and all participants are no longer experiencing severe hypoglycemic events. 

While there are currently no approved stem cell-derived islet therapies for T1D, Breakthrough T1D has funded research toward this goal for decades. This trial represents the next step in making these therapies an accessible option for those who live with T1D.