Updated: Quince eyes PhIII trial start for rare pediatric disease drug-device as FDA lifts clinical hold
The FDA has lifted a temporary clinical hold on EryDel’s IND for its rare disease drug-device product, boding well for California biotech Quince Therapeutics, which is set to acquire EryDel.
Quince should now be able to proceed as planned with the placebo-controlled Phase III NEAT trial of the drug-device combination, EryDex, in children with ataxia-telangiectasia (A-T). The FDA had hit pause on NEAT in October 2022 to request information on the change in plastics used in the device portion.
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