- 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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