Vertex Reports the FDA’s Clinical Hold on P-I/II Study of VX-880 for the Treatment of Type 1 Diabetes
- The US FDA placed the clinical hold on the P-I/II study of VX-880 due to a determination that there is insufficient information to support dose escalation with the product
- The first patient dosed in Part A of the study achieved insulin independence @Day 270, with a HbA1c of 5.2%. The second patient dosed in Part A demonstrated robust increases in fasting and stimulated C-peptide, and reductions in exogenous insulin requirements @Day 150
- Following the dosing of 2 patients, the IDMC recommended the study advance to the second part, where patients have begun to receive the full target dose of VX-880 and have been followed for 29 days. The drug was well tolerated across the clinical program
Ref: Businesswire | Image: Vertex
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