The FDA has notified Prevail Therapeutics (NASDAQ:PRVL) that its Investigational New Drug (IND) application for PR001 for the treatment of neuronopathic Gaucher disease (nGD) patients is now active and that Prevail may proceed with initiating its proposed clinical trial.
Prevail’s IND for PR001 had been put on clinical hold by the FDA, and this clinical hold has now been removed.
The Company’s planned Phase 1/2 clinical trial for nGD patients will commence at a dose higher than originally proposed. Patient dosing in the trial for Type 2 Gaucher is expected during H1 2020.
The Company also plans to initiate a Phase 1/2 clinical trial for Type 3 Gaucher disease patients in H2 2020, under the same nGD IND.
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