Aeglea Bio Stock Gains On Additional Pegzilarginase Data For Rare Metabolic Disease

Aeglea BioTherapeutics Inc AGLE shared additional data from the PEACE Phase 3 study evaluating Pegzilarginase in Arginase 1 Deficiency.
Arginase-1 deficiency is a rare inherited disorder characterized by a complete or partial lack of the enzyme arginase in the liver and red blood cells. Arginase plays a role in the breakdown and removal of nitrogen from the body, a process known as the urea cycle.
The data were shared at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting.
In an analysis of individual patients, eleven patients (65%) treated with pegzilarginase reached or exceeded prespecified response criteria for at least one mobility assessment compared to four patients (44%) receiving a placebo.
Related: Why Did Aeglea BioTherapeutics Shares Nosedived To 52-Week Low On Monday Premarket?
Eight patients (47%) met or exceeded prespecified clinical response criteria for at least two of the mobility outcomes compared to no patients receiving a placebo.
Six patients meeting or exceeding the clinical response threshold for at least two mobility outcomes showed no worsening on any other mobility endpoint.
In a post hoc analysis correcting for a missed assessment that was improperly scored as 0 rather than "not assessed," the least-squares mean GMFM-D score of pegzilarginase treated patients improved from baseline by 2.25 units to placebo (p=0.0896).
Aeglea submitted an FDA marketing application for pegzilarginase in Arginase 1 Deficiency, and requested for Priority Review.
European marketing application on track for submission this year.
Price Action: AGLE shares are up 27.6% at $3.10 during the premarket session on the last check Tuesday.

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Aeglea Bio Stock Gains On Additional Pegzilarginase Data For Rare Metabolic Disease