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Vertex Reports the FDA’s Clinical Hold on P-I/II Study of VX-880 for the Treatment of Type 1 Diabetes

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Vertex Reports the FDA’s Clinical Hold on P-I/II Study of VX-880 for the Treatment of Type 1 Diabetes

Shots:

  • 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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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