DS-7011 / Daiichi Sankyo, U Tokyo - LARVOL DELTA

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: Daiichi Sankyo | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=26 | Active, not recruiting | Sponsor: Daiichi Sankyo | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of DS-7011a, an Anti-TLR7 Antagonistic Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus. (PubMed, J Clin Pharmacol) - P1 | "Pharmacodynamic (PD) response also increased with the dose and at the higher doses was of large extent (>90%), early onset, and lasting duration. DS-7011a showed favorable safety, pharmacokinetics, immunogenicity, and PD properties that support its development for the treatment of SLE."

Journal • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IL6

TRANSCRIPTOME ANALYSIS IMPLICATES TOLL-LIKE RECEPTOR 7 RATHER THAN TOLL-LIKE RECEPTOR 8 IN THE PATHOGENESIS OF SYSTEMIC LUPUS ERYTHEMATOSUS (EULAR 2024) - "TLR7 GS scores remained higher in SLE patients than healthy subjects, even when treated with standard therapies such as steroids, hydroxychloroquine, and mycophenolate mofetil (Figure 1b ). These results indicate that TLR7 rather than TLR8 is involved in the pathogenesis of SLE. TLR7 involvement is evident under various conditions of treatment and ethnicity. These results support TLR7 as a critical pharmacological target against SLE rather than TLR8, justifying and valorizing the development of DS-7011a, a TLR7-specific inhibitor, for the treatment of SLE."

IO biomarker • Cutaneous Lupus Erythematosus • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TLR7 • TLR8

PHARMACOKINETIC-PHARMACODYNAMIC RELATIONSHIP JUSTIFIES DOSE SELECTION OF DS-7011A, AN ANTI-TLR7 MONOCLONAL ANTIBODY, FOR THE TREATMENT OF ASIAN PARTICIPANTS IN AN ONGOING GLOBAL PHASE 1B STUDY OF DS-7011A IN SYSTEMIC LUPUS ERYTHEMATOSUS (EULAR 2024) - P1/2 | "DS-7011a exhibited concentration-dependent, saturable inhibition of ex vivo IL-6 production in HV, across all the evaluated races. Simulated DS-7011a PK exposure and ex vivo IL-6 inhibition after DS-7011a 20 mg/kg IV Q4W is comparable between Asian and non-Asian SLE patients, supporting the inclusion of Asian participants at this dosing regimen selected for the ongoing Phase 1b study of DS-7011a in SLE."

Clinical • IO biomarker • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TLR7

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Daiichi Sankyo | Trial completion date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Phase classification: P1b/2 ➔ P1/2

Phase classification • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Selection of the Dose for Subcutaneous Administration to Non-Japanese Subjects and Intravenous Administration to Japanese Subjects in the First-in-Human Study of DS-7011a, an Anti-TLR7 Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus (ACR Convergence 2023) - P1 | "Model prediction of SAD SC doses for non-Japanese HV and IV dose for Japanese HV is confirmed by emerging clinical PK data and demonstrates the value of model-informed dose selection for DS-7011a FIH. Additional analysis will be conducted to select DS-7011a dose for future treatment of SLE patients."

Clinical • IO biomarker • P1 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IL6 • TLR7

First-in-Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of DS-7011a, an Anti-TLR7 Antagonistic Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus (ACR Convergence 2023) - P1 | "DS-7011a, a mAb that specifically antagonizes TLR7, was generally safe and well tolerated and showed appealing PK and PD properties that support its development for the treatment of SLE. G. Senaldi: Daiichi Sankyo, 3; A. Mohan: Daiichi Sankyo, 3; L. Zhang: Daiichi Sankyo, 3, Regeneron, 3; J. Tanaka: Daiichi Sankyo, 3, The Japan Agency for Medical Research and Development, 5; G. Pandya: Daiichi Sankyo, 3; S. Grossman: Daiichi Sankyo, 3;"

Clinical • IO biomarker • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Orthopedics • Systemic Lupus Erythematosus • IL6

Targeting Toll-Like Receptor 7 with DS-7011a, a Promising Novel Antagonistic Antibody for the Treatment of Systemic Lupus Erythematosus (ACR Convergence 2023) - "DS-7011a shows the ability to inhibit the TLR7-stimulated production of inflammatory cytokines and shows no toxicity in monkeys after 3-month treatment up to and including the maximum administered dose. An anti-mouse TLR7 mAb ameliorated manifestations of a mouse lupus model, suppressing the expression of TLR7 GS. These findings indicate that, by targeting TLR7, DS-7011a is a promising therapeutic option for the treatment of SLE."

IO biomarker • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNA1 • IL6 • TLR7

A Study of DS-7011a in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus (clinicaltrials.gov) - P1b/2 | N=24 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Daiichi Sankyo, Inc. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IL6 • TLR7

A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Daiichi Sankyo, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IL6 • TLR7

A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IL6 • TLR7