Annexon, Inc. · NASDAQ:ANNX
Annexon — Technical Presentation (March 2022)
11 slides from Annexon's technical presentation, Mar 10, 2022
Slide 1: Effect of Combined Intravenous Immunoglobulin and Classical Complement Inhibitor ANX005 in GBS
Effect of Combined Intravenous Immunoglobulin and Classical Complement Inhibitor ANX005 in Guillain-Barré Syndrome (GBS) Thomas Harbo1, Zhahirul Islam2, Nowshin Papri2, Shoma Hayat2, Ananna Rahman2, Israt Jahan2, Gurudas Mondal4, Sadekur Rahman Sarkar4, Eric Humphriss3, Ping Lin3, Sanjay Keswani3, R
Slide 2: Inhibiting C1q Upstream With ANX005 Prevents Downstream Activation of All Tissue-Damaging Components in GBS
Inhibiting C1q Upstream With ANX005 Prevents Downstream Activation of All Tissue-Damaging Components in GBS Enzymatic amplification C1r C1s C2 FB C6-C9 Classical Pathway C1q C4 C3 C5 Immune cell attack Membrane & recruitment damage C 3 POTENTIAL EFFICACY ADVANTAGE: Shuts down all d tissue-damaging c
Slide 3: Open-Label Drug-Drug Interaction (DDI) Study in Patients With GBS From Bangladesh and Denmark
Open-Label Drug-Drug Interaction (DDI) Study in Patients With GBS From Bangladesh and Denmark First trial in GBS evaluating patients from Bangladesh and Denmark with single treatment regimen METHODS: • Open-label DDI study of a single dose of ANX005 75 mg/kg given during first 3 days of standard IVI
Slide 4: Preliminary Results: Safety / Tolerability Data
Preliminary Results: Safety / Tolerability Data Combined use of ANX005 and IVIg was well tolerated • All 14 patients with GBS experienced ≥1 treatment-emergent ANX005 + IVIg (N=14) CATEGORY n (%) adverse event (TEAE), mainly grades 1 and 2 Any TEAE 14 (100) • One patient reported one serious adverse
Slide 5: Preliminary Results: PK and PD
Preliminary Results: PK and PD Achieved full C1q target engagement and maintained duration of C1q suppression within 1–3-week targeted window PHARMACOKINETICS PHARMACODYNAMICS • As anticipated, minimal reduction in exposure due to • Full target engagement in all subjects enhanced IgG clearance by IV
Slide 6: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics Bangladeshi patients enrolled later and had more severe disease than Danish patients with GBS ALL BANGLADESH DENMARK PARAMETER N=14 n=11 n=3 Age, mean (range) 41.1 (18-72) 33.3 (18-52) 54.7(28-72) Male, n (%) 12 (85.7) 10 (90.9) 2 (66.7) Days from symptoms t
Slide 7: Early Improvement in Muscle Strength (MRC-Sum Score) in DDI Study
Early Improvement in Muscle Strength (MRC-Sum Score) in DDI Study Muscle Strength Over 26 Weeks 60 • Improvement in muscle strength (MRC-sum score) observed within 1 week of initiating treatment • MRC-sum score is the most significant predictor of functional outcomes (modified Erasmus GBS MRC Sum Sc
Slide 8: Two Clusters of GBS Patients Defined by Baseline Serum NfL and Muscle Strength
Two Clusters of GBS Patients Defined by Baseline Serum NfL and Muscle Strength With Different Trajectories to Functional Recovery Top cluster consisting of Bangladeshi and Danish patients having similar functional outcomes at Week 26 Pattern of change in function over time favors a longitudinal anal
Slide 9: Preliminary Results: Serum NfL as an Important Prognostic Biomarker
Preliminary Results: Serum NfL as an Important Prognostic Biomarker Baseline sNfL and Change from Baseline in GBS-DS at Wk26 (N=13) • Baseline serum neurofilament light (sNfL) was elevated in all subjects 4 r=0.86 (range, 64-3445 pg/ml) ▪ NfL levels are presented as log-transformed values 3 log seru
Slide 10: Summary
Summary • IVIg-ANX005 combination treatment was well tolerated with no change relative to safety profile of either IVIg or ANX005 • Full C1q target engagement was observed in all subjects • C1q suppression was maintained within the 1–3-week targeted range of complement inhibition • Baseline MRC-sum
Slide 11: Thank You
Thank You