Vertex Pharmaceuticals’ investigational allogeneic insulin-producing islet cell therapy, VX-880, has shown promising results in a phase 1/2 clinical trial (NCT04786262) treating patients with type 1 diabetes. The FORWARD study, announced at the American Diabetes Association’s 85th Scientific Sessions, demonstrated that all 12 patients treated with VX-880 showed restored endogenous insulin secretion, as assessed via C-peptide levels.
The therapy also reduced the need for exogenous insulin, with a mean decrease of 92% across patients. Ten out of 12 patients no longer required exogenous insulin treatment. The study’s results suggest that VX-880 has the potential to improve glycemic control in T1D patients who struggle with achieving target blood sugar levels.
The therapy was generally well-tolerated, with adverse events (AEs) consistent with those expected for islet infusion procedures and immunosuppressive regimens. No additional AEs were reported.
According to investigator Michael Rickels, the findings indicate a novel cellular therapy that can restore endogenous insulin secretion, improving outcomes for T1D patients. The company plans to initiate a separate study evaluating VX-880 in patients who have previously received a kidney transplant and are on immunosuppressive therapy regimens.
The phase 3 trial is expected to finish enrollment by the end of this year, with Vertex aiming to dose around 50 patients. The trial had been paused twice due to patient deaths deemed unrelated to the therapy, but has since resumed and received FDA clearance in July 2022.
Source: https://www.cgtlive.com/view/vertex-islet-cell-therapy-vx-880-restores-endogenous-insulin-secretion-type-1-diabetes