Slide 1: PEACE Phase 3 Topline Study Results
Reimagining The Potential Of Human Enzyme Therapeutics PEACE Phase 3 Topline Study Results – December 6, 2021 Exhibit 99.2
Slide 2: Forward Looking Statements
Forward Looking Statements ©2021 Aeglea BioTherapeutics. External 2 This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statement
Slide 3: PEACE Phase 3 Study of Pegzilarginase in Patients with ARG1-D
PEACE Phase 3 Study of Pegzilarginase in Patients with ARG1-D ©2021 Aeglea BioTherapeutics. External 3 Thank you to all the patients, families, investigators and study staff who participated in the PEACE study
Slide 4: PEACE Phase 3 Topline Study Results: Pegzilarginase in Arginase 1 Deficiency
PEACE Phase 3 Topline Study Results Pegzilarginase in Arginase 1 Deficiency Draft for Internal Discussion Only
Slide 5: First Potential Therapy to Normalize Plasma Arginine Levels in ARG1-D
©2021 Aeglea BioTherapeutics. External 5 First Potential Therapy to Normalize Plasma Arginine Levels in ARG1-D Lowering Plasma Arginine Accompanied by Improvement in Mobility Pivotal Data Supports Planned BLA Submission in First Half of 2022 Substantial Reduction in Plasma Arginine Impact on Mobilit
Slide 6: PEACE Phase 3 Study Design
PEACE Phase 3 Study Design ©2021 Aeglea BioTherapeutics. External 6 *Dosing is weekly and, if needed, dose is modified based on plasma arginine levels with maintenance of blinding. ǂThe first 8 weeks of the open-label extension will be blinded. All study participants remain on current disease manage
Slide 7: PEACE Baseline Demographics
PEACE Baseline Demographics ©2021 Aeglea BioTherapeutics. External 7 Demographic Characteristic Pegzilarginase n=21 Placebo n=11 Overall N=32 Age at Enrollment, y Mean (SD) 9.6 (6.16) 12.9 (6.77) 10.7 (6.47) Range 2-28 5-29 2-29 Age Category, n (%) 2y to less than 6y 5 (23.8) 1 (9.1) 6 (18.8) 6y to
Slide 8: PEACE Baseline Clinical Characteristics
PEACE Baseline Clinical Characteristics ©2021 Aeglea BioTherapeutics. External 8 *Based on arithmetic mean Clinical Characteristic Pegzilarginase n=21 Placebo n=11 Overall N=32 Plasma Arginine, µM/L Mean* (SD) 365.4 (93.7) 471.7 (79.9) 402.0 (101.8) Median (range) 368.2 (202-572) 483.7 (294-573) 398
Slide 9: Marked and Sustained Reduction in Plasma Arginine
©2021 Aeglea BioTherapeutics. External 9 Highly elevated plasma arginine despite standard of care Mean plasma arginine* Pegzilarginase Baseline: 365.4 µM 24-week: 105.5 µM Placebo Baseline: 471.7 µM 24-week: 448.8 µM Primary Endpoint – 24-Week Analysis 80% reduction in mean plasma arginine with pegz
Slide 10: Normalization of Plasma Arginine Levels in ARG1-D Patients
90.5% of pegzilarginase treated patients achieved normal plasma arginine levels (p<0.0001)* No meaningful change in plasma arginine levels in placebo arm Treatment with pegzilarginase surpassed current clinical guideline goals of reducing arginine levels below 200 µM ©2021 Aeglea BioTherapeutics. Ex
Slide 11: PEACE Key Mobility Measurements
©2021 Aeglea BioTherapeutics. External 11 Gross Motor Function Measure (GMFM) Part E Assesses unaided mobility without bracing or assistive devices 24 tasks involving walking forward/backward, running, jumping and ascending/descending stairs, each scored from 0 to 3 with a total score range of 0-72
Slide 12: Positive Trend in GMFM-E in Pegzilarginase Treated Patients
Positive Trend in GMFM-E in Pegzilarginase Treated Patients ©2021 Aeglea BioTherapeutics. External 12 Mean Change from Baseline in GMFM-E Positive Trend in GMFM-E in Placebo Controlled Study Suggests Potential Improvements in Mobility Mean Change from Baseline (units) Pegzilarginase Placebo 12 Weeks
Slide 13: Mobility Assessment by 2-Minute Walk Test
©2021 Aeglea BioTherapeutics. External 13 Mobility Assessment by 2-Minute Walk Test 6MWT – Six Minute Walk Test 2MWT = 2-Minute Walk Test Mean Change from Baseline in 2MWT 6.8 -7.5 7.3 2.7 -10 0 10 Pegzilarginase Placebo Mean Change from Baseline (m) Pegzilarginase Placebo 12 Weeks 24 Weeks 12 Weeks
Slide 14: PEACE Safety Profile
©2021 Aeglea BioTherapeutics. External 14 PEACE Safety Profile * TEAE: Treatment-Emergent Adverse Event; ǂ SAE: Serious Adverse Event; ♢ Adverse Event of Interest Pegzilarginase was Well-Tolerated with No Discontinuations Due to Adverse Events Patients With: Pegzilarginase n (%) Placebo n (%) Any TE
Slide 15: First Potential Therapy to Normalize Plasma Arginine Levels in ARG1-D
©2021 Aeglea BioTherapeutics. External 15 First Potential Therapy to Normalize Plasma Arginine Levels in ARG1-D Lowering Plasma Arginine Accompanied by Improvement in Mobility Pivotal Data Supports Planned BLA Submission in First Half of 2022 Substantial Reduction in Plasma Arginine Impact on Mobili
Slide 16: Robust Data Package Generated For Pegzilarginase Program
Robust Data Package Generated For Pegzilarginase Program ©2021 Aeglea BioTherapeutics. External 16 Clinical Data Manufacturing Regulatory Designations PEACE demonstrated normalization of elevated plasma arginine levels accompanied by a positive trend in mobility assessment Favorable long-term data f
Slide 17: ARG1-D Patient Needs Not Adequately Addressed by Standard of Care
©2021 Aeglea BioTherapeutics. External 17 ARG1-D Patient Needs Not Adequately Addressed by Standard of Care Current standard of care: Severe dietary protein restriction Amino acid supplementation Ammonia scavengers Current disease management is inadequate: Limited effectiveness Challenging to mainta
Slide 18: Attractive Commercial Opportunity for Pegzilarginase in ARG1-D
©2021 Aeglea BioTherapeutics. External 18 Attractive Commercial Opportunity for Pegzilarginase in ARG1-D Severe and progressive disease with early mortality Easily diagnosed but often missed due to lack of awareness Standard of care provides poor control of plasma arginine levels No approved therapi
Slide 19: Building the Foundation for a Successful Launch
©2021 Aeglea BioTherapeutics. External 19 Building the Foundation for a Successful Launch and Enduring Commercial Presence Patient Identification Accelerating the diagnosis and identification of patients through ongoing HCP engagement Disease Education and Awareness Driving HCP dialogue about the de
Slide 20: Committed to Delivering Innovative Therapies for Patients in Need
©2021 Aeglea BioTherapeutics. External 20 Committed to Delivering Innovative Therapies for Patients in Need Countries included in Immedica license and supply agreement – European Economic Area, United Kingdom, Switzerland, Andorra, Monaco, San Marino, Vatican City, Turkey, Saudi Arabia, United Arab
Slide 21: Aeglea's Human Enzyme Platform for Rare Metabolic Diseases
©2021 Aeglea BioTherapeutics. External 21 Aeglea’s Human Enzyme Platform for Rare Metabolic Diseases 1 Ex-U.S. license and supply agreement with Immedica to commercialize pegzilarginase in Europe and certain countries in the Middle East (European Economic Area, United Kingdom, Switzerland, Andorra,
Slide 22: Q&A
Q&A
Slide 23: Aeglea contact details
805 Las Cimas Parkway Suite 100 Austin, TX 78746 aeglea.com