Roche Holding Ltd · SIX:RO
Roche — American Society of Retina Specialists Annual Meeting 2024
12 slides from Roche's conference presentation, Jul 17, 2024
Slide 1: IL-6 Inhibition With Vamikibart in Patients With Uveitic Macular Edema: Phase 3 MEERKAT and SANDCAT Trials
IL-6 Inhibition With Vamikibart in Patients With Uveitic Macular Edema: Phase 3 MEERKAT and SANDCAT Trials Anat Loewenstein, MD,1 Laura Steeples, MBChB (Hons), FRCOphth,2 Markus C. Elze, PhD,3 Lachlan Macgregor, MBBS, MMedSc, Mbios,3 Ivo Stoilov MD,4 David Silverman, MSc, MBChB, MRCOphth,2 Marina Me
Slide 2: Disclosures
Disclosures • Financial Disclosures – AL: Consultant, 4DMT, Abbvie, Alkeus, Annexon, Apellis, Astellas, Bayer health care, Beyeonics, Eyepoint, J & J, NotalVision, Novartis, Ocular Therapeutics, Ocuphire Pharma, Ocuterra, Oculis, Opthea, Oxurion, Roche, Syneos – LS, DS: Employee, Roche Products Ltd.
Slide 3: Unmet Need in the Treatment of Uveitic Macular Edema
Unmet Need in the Treatment of Uveitic Macular Edema • UME is the most frequent sight-threatening complication of noninfectious uveitis and is the leading cause of vision loss,1 affecting around one-third of patients2 The goal is to develop • There is a high unmet need in UME for novel, nonsteroidal
Slide 4: IL-6 is a Potential Target to Address the Inflammatory Cascade in Retinal Diseases
IL-6 is a Potential Target to Address the Inflammatory Cascade in Retinal Diseases • Pleiotropic cytokine implicated in a wide variety of biological processes1-3 • Upregulated during infection and inflammation1,2 • Involved in angiogenesis, fibrosis, inflammation, and blood–retinal barrier integrity
Slide 5: Anti–IL-6 Monoclonal Antibody Vamikibart Engineered for Intravitreal Use
Anti–IL-6 Monoclonal Antibody Vamikibart Engineered for Intravitreal Use Recombinant fully humanized Specifically engineered for IVT delivery immunoglobulin G2 isotype mAb Fragment crystallizable region designed for fast systemic clearance and to minimize potential for systemic adverse events Half-l
Slide 6: Preclinical and Clinical Evidence Support Targeting IL-6 in UME Secondary to NIU
Preclinical and Clinical Evidence Support Targeting IL-6 in UME Secondary to NIU DAPI ZO-1 F-Actin VE-Cadherin IL-6 + sIL-6R RG6179 Untreated Control TEER, % + IL-6 + IL-6R + IL-6 + IL-6R + RG6179 Time, Hours TEER in HUVEC After RG6179 Tight Junctions After RG6179 In a TEER assay, IL-6/IL-6R led to
Slide 7: Preliminary Efficacy and Safety Data in DOVETAIL Phase 1 Trial
Preliminary Efficacy and Safety Data in DOVETAIL Phase 1 Trial Supported Progression Directly to Phase 3 Development1 • Patients received vamikibart 0.25, 1 or 2.5mg IVT at week 0, 4, and 8, and were followed up to week 36 Improved Vision (BCVA) Across all Doses Reduced Retinal Thickness (CST) Acros
Slide 8: Case Example of a Patient with UME in DOVETAIL Phase 1 Trial
Case Example of a Patient with UME in DOVETAIL Phase 1 Trial OCT animations: Carl Glittenberg • Diagnosis: Uveitis associated with ankylosing spondylitis • Receiving systemic methotrexate • Vamikibart dose: 2.5 mg (3 doses, Q4W) • Change from baseline in BCVA: +25 letters at week 12 BCVA, best corre
Slide 9: MEERKAT and SANDCAT Study Site Map
MEERKAT and SANDCAT Study Site Map • MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are 2 ongoing, identical, global, parallel, multicenter, randomized, double-masked, sham comparator–controlled, phase 3 trials to evaluate the efficacy, safety, PK/PD of IVT anti–IL-6 biologic therapy vamikibart in
Slide 10: MEERKAT and SANDCAT Trials Design
MEERKAT and SANDCAT Trials Design • Adult patients with UME secondary to NIU: CST ≥ 325um + BCVA decrease due to UME with ETDRS score 73–19 letters • All NIU aetiologies and all anatomical types allowed. Active or inactive NIU at baseline allowed • Concomitant maintenance therapies for background uv
Slide 11: MEERKAT and SANDCAT Trials Will Evaluate Efficacy, Safety, and PK/PD of Vamikibart
MEERKAT and SANDCAT Trials Will Evaluate Efficacy, Safety, and PK/PD of Vamikibart Visual function Primary • Proportion of patients with a ≥ 15-letter gain from baseline at week 20 (8 weeks after last study drug dose) endpoint: • Change in BCVA score from baseline at week 16 Key secondary Anatomical
Slide 12: Conclusions
Conclusions • Vamikibart represents a potential nonsteroidal immunomodulatory treatment option for local IVT delivery in patients with UME secondary to NIU • MEERKAT and SANDCAT are 2, global, phase 3 trials designed to investigate IL-6 signalling inhibition with IVT vamikibart in participants with
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