AGLE - Aeglea stock dips as FDA places partial hold on enrolling under 18 patients in metabolic disorder trial

Aeglea BioTherapeutics ( NASDAQ: AGLE ) stock fell ~5% on Oct. 4 after the company said the U.S. Food and Drug Administration (FDA) placed a phase 1/2 trial of pegtarviliase on partial clinical hold for the enrollment of patients less than 18 years of age.

The company had submitted a protocol amendment for the study of pegtarviliase to treat Classical Homocystinuria, which among other things requested the inclusion of adolescent patients at trial sites in the U.S.

Aeglea said that the the FDA stated the protocol did not provide adequate justification and evidence to support the prospect of direct clinical benefit for pediatric patients and placed the trial on partial clinical hold for the enrollment of patients less than 18 years of age under this Investigational New Drug (IND) at this time.

The company added that it intends to address the feedback from the FDA and aims to satisfy the requirements for prospective benefit for future inclusion of pediatric patients under the IND, including in a potential pivotal trial.

Aeglea expects the FDA letter will not have an impact on the planned enrollment and dosing of patients aged 18 years and older in the U.S. or patients aged 12 years and older in the U.K. and Australia.

Aeglea expects to report data in Q4, including data from cohort 3 in which dosing has begun.

Homocystinuria is a rare metabolic condition characterized by an excess of the compound homocysteine in the urine and blood.

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