FDA Puts Partial Hold On Aeglea's Rare Disorder Trial In Pediatric Patients

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  • Aeglea BioTherapeutics Inc AGLE received an FDA letter responding to a recently submitted protocol amendment for the Phase 1/2 trial of pegtarviliase for Classical Homocystinuria.
  • Classical Homocystinuria is a rare disorder of methionine metabolism, leading to an abnormal accumulation of homocysteine and its metabolites in blood and urine.
  • The protocol amendment requested the inclusion of adolescent patients at clinical trial sites in the U.S. 
  • The FDA stated that the protocol did not provide adequate justification and evidence to support the prospect of direct clinical benefit for pediatric patients.
  • Also ReadAeglea Bio Feels FDA Refusal Pinch, Cuts Workforce, Shifts Pipeline Focus
  • The agency placed the trial on partial clinical hold for enrolling patients under 18 years of age under this Investigational New Drug (IND). 
  • The company believes the letter will not impact the planned enrollment and dosing of patients aged 18 & above.
  • Enrollment in the trial remains on track, and Aeglea continues to expect to announce data in the fourth quarter of 2022, including data from cohort 3. 
  • Price Action: AGLE shares are down 3.64% at $0.53 on the last check Tuesday.
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