by Denny Jacob
Quince Therapeutics announced its plans to move forward with trials on EryDex after the U.S. Food and Drug Administration (FDA) lifted the hold on EryDel’s investigational new drug application.
Advancing Clinical Trial for Ataxia-Telangiectasia Treatment
The biotechnology company aims to launch a clinical trial to assess the safety and effectiveness of EryDex for the potential treatment of Ataxia-Telangiectasia. This rare and fatal pediatric neurological disease will be the focus of the trial once Quince completes its acquisition of EryDel. It is worth noting that the FDA had previously placed a partial clinical hold on the EryDex application.
Special Protocol Assessment with the FDA
Quince Chief Executive Dirk Thye stated, “This pivotal trial will be conducted under a Special Protocol Assessment that has already been reviewed with the FDA.” The company’s goal is to submit a new drug application upon completion of this single study, assuming positive results.
Acquisition Closing Expected in Fourth Quarter
Quince anticipates finalizing its acquisition of EryDel in the fourth quarter, enabling them to proceed with their plans.