Delving into the Latest Updates on Brivekimig with Synapse

Overview

Basic Info

Drug Type

Nanobody

Synonyms

Anti-TNFa and OX40L (Sanofi), Anti-TNFa/OX40L (Sanofi)

+ [1]

Target

OX40L x TNF-α

Mechanism

OX40L inhibitors(Tumor necrosis factor ligand superfamily member 4 inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Infectious DiseasesCardiovascular DiseasesSkin and Musculoskeletal Diseases+ [2]

Active Indication

Glomerulosclerosis (disorder)Glomerulosclerosis, Focal SegmentalNephrosis, Lipoid+ [1]

Inactive Indication-

Originator Organization

Sanofi

Active Organization

SanofiSanofi-Aventis Recherche et Développement SA

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 719981899H

Source: *****

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Start Date19 Dec 2024

Sponsor / Collaborator

Sanofi

JPRN-jRCT2071230056

/ Not yet recruitingPhase 1IIT

A Phase 1, open-label, randomized, 2-arm, parallel design study to evaluate the pharmacokinetics, safety, and tolerability of single subcutaneous dose of SAR442970 in healthy adult Japanese participants

Start Date26 Sep 2023

Sponsor / Collaborator-

NCT05849922

/ Active, not recruitingPhase 2

A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa

This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.

Start Date06 Jun 2023

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Brivekimig

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100 Translational Medicine associated with Brivekimig

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100 Patents (Medical) associated with Brivekimig

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28

Literatures (Medical) associated with Brivekimig

15 Oct 2024·The Journal of Clinical Endocrinology & Metabolism

Regulation of the Function of T Follicular Helper Cells and B Cells in Type 1 Diabetes Mellitus by the OX40/OX40L Axis

Article

Author: Lu, Wen ; Zhu, Yan ; Fu, Nannan ; Du, Xuan ; Shi, Bimin ; Wang, Qin

AbstractObjective/Main OutcomeTo study the expression of OX40 on T follicular helper (Tfh) cells and the ligand OX40L on antigen-presenting cells (APCs) in peripheral blood of patients with type 1 diabetes mellitus (T1DM) and the role of OX40 signaling in promoting Tfh cells to assist B-cell differentiation.DesignCross-sectional study.SettingEndocrinology department of a university hospital.ParticipantsTwenty-five patients with T1DM and 35 with newly diagnosed type 2 diabetes mellitus (T2DM) from January 2021 to December 2021 (39 males, 21 females; mean age: 31.0 ± 4.5, range: 19-46 years).InterventionsNone.MethodsThe peripheral blood proportion of CD4+CD25−CD127+CXCR5+PD1+ Tfh cells in patients with T1DM or T2DM and the OX40L expression in CD14+ monocytes and CD19+ B cells were analyzed by flow cytometry. The OX40 signal effect on Tfh-cell function was analyzed by coincubating B cells with Tfh cells under different conditions. Flow cytometry detected the ratio of CD19−CD138+ plasmacytes.ResultsThe Tfh cells ratio and intracellular IL-21 expression in peripheral blood was significantly higher in patients with T1DM than with T2DM, and the OX40 expression in peripheral Tfh cells and OX40L expression in APC were significantly higher in T1DM. After adding OX40L protein, the CD19−CD138+-plasmacytes percentage was significantly increased and higher in T1DM. Blocking of anti-OX40L monoclonal antibodies significantly reduced the plasmacytes ratio.ConclusionThe peripheral Tfh cells proportion increased and the OX40 expression in peripheral Tfh cells was upregulated in patients with T1DM vs patients with T2DM. OX40/OX40L signaling enhanced the Tfh-cell function to assist B-cell differentiation, which may contribute to the pathogenesis of T1DM.

01 Jun 2024·Allergy

Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs

Review

Author: Maintz, Laura ; Müller, Svenja ; Bieber, Thomas

AbstractAtopic dermatitis (AD) represents the most common skin disease characterized by heterogeneous endophenotypes and a high disease burden. In Europe, six new systemic therapies for AD have been approved: the biologics dupilumab (anti‐interleukin‐4 receptor (IL‐4R) α in 2017), tralokinumab (anti‐IL‐13 in 2021), lebrikizumab (anti‐IL‐13 in 2023), and the oral janus kinase (JAK) inhibitors (JAKi) targeting JAK1/2 (baricitinib in 2020 in the EU) or JAK1 (upadacitinib in 2021 and abrocitinib in 2022). Herein, we give an update on new approvals, long‐term safety, and efficacy. Upadacitinib and abrocitinib have the highest short‐term efficacy among the approved systemic therapies. In responders, dupilumab and tralokinumab catch up regarding long‐term efficacy and incremental clinical benefit within continuous use. Recently, the European Medicines Agency has released recommendations for the use of JAKi in patients at risk (cardiovascular and thromboembolic diseases, malignancies, (former) smoking, and age ≥65 years). Furthermore, we give an overview on emerging therapies currently in Phase III trials. Among the topical therapies, tapinarof (aryl hydrocarbon receptor), ruxolitinib (JAK1/2i), delgocitinib (pan‐JAKi), asivatrep (anti‐transient receptor potential vanilloid), and phosphodiesterase‐4‐inhibitors (roflumilast, difamilast) are discussed. Among systemic therapies, current data on cord‐blood‐derived mesenchymal stem cells, CM310 (anti IL‐4Rα), nemolizumab (anti‐IL‐31RA), anti‐OX40/OX40L‐antibodies, neurokinin‐receptor‐1‐antagonists, and difelikefalin (κ‐opioid‐R) are reported.

25 Oct 2023·British Journal of Dermatology

Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial

Article

Author: Reich, Adam ; Quaratino, Sonia ; O’Malley, John T ; Brennan, Nuala ; Cork, Michael J ; Gilbert, Sally ; Weidinger, Stephan ; Bieber, Thomas ; Wilson, Rosamund ; Stebegg, Marisa ; Porter-Brown, Ben

AbstractBackgroundAtopic dermatitis (AD) is an inflammatory skin disease with significant unmet need. Blockade of the OX40–OX40 ligand (OX40L) costimulation pathway by targeting OX40L on antigen-presenting cells (APCs) with a fully human noncytotoxic, nondepleting anti-OX40L monoclonal antibody (amlitelimab; SAR445229; KY1005) is a novel way to modulate persistent inflammation.ObjectivesTo assess the safety and efficacy of amlitelimab over 16 weeks in adults with AD in a phase IIa double-blind placebo-controlled study.MethodsThe study was conducted at 19 hospitals in Germany, Poland, Spain and the UK. Eligible patients with moderate-to-severe AD were randomized (1 : 1 : 1) to low-dose intravenous (IV) amlitelimab (200 mg), high-dose IV amlitelimab (500 mg) or placebo, followed by three maintenance doses (50% of loading dose) at 4, 8 and 12 weeks, with safety follow-up to week 36. The co-primary endpoints were the incidence of treatment-emergent adverse events (all patients who received ≥ 1 dose of the study drug) and mean percentage change in Eczema Area and Severity Index (EASI) to week 16 (full analysis set).ResultsBetween 13 December 2018 and 12 May 2020, 89 patients were randomly assigned to low- (n = 29) or high-dose amlitelimab (n = 30) or placebo (n = 29), of whom 88 proceeded to treatment [37 women (42%), 51 (58%) men; mean (SD) age 33.6 (11.9) years]. Amlitelimab was generally well tolerated with an unremarkable safety profile; no hypersensitivity events were reported. For the primary endpoint, the least square mean percentage change in EASI from baseline to week 16 was –80.12% [95% confidence interval (CI) –95.55 to –64.68; P = 0.009 vs. placebo] and –69.97% (95% CI –85.04 to –54.60; P = 0.07 vs. placebo) for the low- (n = 27) and high-dose (n = 27) amlitelimab groups, respectively, vs. –49.37% (95% CI –66.02 to –32.72) for placebo (n = 24). Numerically greater reductions in EASI were observed for amlitelimab vs. placebo from weeks 2 to 16.ConclusionsNovel targeting of OX40L-expressing APCs with amlitelimab was well tolerated and resulted in clinically meaningful improvements in AD.

100 Deals associated with Brivekimig

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hidradenitis Suppurativa	Phase 2	CA	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	NL	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	SE	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	BE	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	DK	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	DE	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	FR	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	ES	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	IT	Sanofi	06 Jun 2023
Hidradenitis Suppurativa	Phase 2	CZ	Sanofi	06 Jun 2023