FDA puts Vertex's phase 1/2 trial of VX-880 for the treatment of diabetes on clinical hold
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Vertex Pharmaceuticals (NASDAQ:VRTX) on Monday said the U.S. Food and Drug Administration (FDA) had placed the company's phase 1/2 study of its insulin producing cell therapy VX-880 for the treatment of type 1 diabetes on clinical hold.
VRTX stock -4.7% to $260.50 in early trading.
The FDA placed the phase 1/2 study on clinical hold in the U.S. after it determined that there is insufficient information to support dose escalation with the product.
The clinical hold comes even as VRTX said data from part A of the phase 1/2 study established proof-of-concept for VX-880 based on 2 patients who received VX-880 at half the target dose.
VRTX said an independent data monitoring committee reviewed the safety and efficacy data from the first two patients dosed in part A of the study and recommended moving the study to part B, where patients will get the full target dose of VX-880.
"We are surprised by the clinical hold placed on the study," said VRTX chief medical officer Carmen Bozic. "We are committed to working with the FDA to understand and address their questions, so that the trial can resume at U.S. sites as soon as possible,â he added.