Quince Therapeutics to Advance Study of EryDex as FDA Lifts Application Hold

By Denny Jacob

Quince Therapeutics said it intends to advance trials on EryDex following the U.S. Food and Drug Administration's hold being lifted on EryDel's investigational new drug application.

The biotechnology company said it intends to advance a clinical trial to evaluate the safety and efficacy of EryDex for the potential treatment of Ataxia-Telangiectasia, a rare and fatal pediatric neurological disease, pending the close of its acquisition of EryDel. The FDA had imposed a partial clinical hold on the application for EryDex.

"This pivotal trial will be conducted under a Special Protocol Assessment that has already been reviewed with the FDA," said Quince Chief Executive Dirk Thye, "which should allow for the submission of a new drug application following completion of this single study, assuming positive results."

Quince said its acquisition is expected to close in the fourth quarter.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

September 28, 2023 16:38 ET (20:38 GMT)

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