Delving into the Latest Updates on MAS-825 with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Target

IL-18 x IL-1β

Action

inhibitors

Mechanism

IL-18 inhibitors(Interleukin 18 inhibitors), IL-1β inhibitors(Interleukin-1 beta inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [5]

Active Indication

Coronary DiseaseHidradenitis SuppurativaAutoinflammation With Infantile Enterocolitis+ [2]

Inactive Indication

COVID-19Respiratory Insufficiency

Originator Organization

Novartis Pharmaceuticals Corp.

Active Organization

Novartis Pharmaceuticals Corp.

Novartis AG

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in an Adult Population With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (VAF ≥2%).

Start Date15 Feb 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06309823

/ CompletedPhase 3IIT

A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency

MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation.

Start Date08 Feb 2023

Sponsor / Collaborator

The Hospital for Sick Children

NCT04641442

/ Active, not recruitingPhase 2

A Three-period Multicenter Study, With a Randomized-withdrawal, Double-blind, Placebo-controlled Design to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations

This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.

Start Date18 Dec 2020

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with MAS-825

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100 Translational Medicine associated with MAS-825

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100 Patents (Medical) associated with MAS-825

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4

Literatures (Medical) associated with MAS-825

01 Mar 2025·Rheumatology

Long-term efficacy of MAS825, a bispecific anti-IL1β and IL-18 monoclonal antibody, in two patients with systemic JIA and recurrent episodes of macrophage activation syndrome

Article

Author: Rosina, Silvia ; Natoli, Valentina ; Ravelli, Angelo ; Palmeri, Serena ; Corcione, Anna ; Gattorno, Marco ; Penco, Federica ; Matucci-Cerinic, Caterina ; Caorsi, Roberta ; Papa, Riccardo ; Viola, Stefania ; Consolaro, Alessandro ; Volpi, Stefano ; Bertoni, Arinna ; Malattia, Clara

AbstractIntroductionSystemic JIA (sJIA), a multifaceted autoinflammatory disorder, can be complicated by life-threatening conditions such as macrophage activation syndrome (MAS) and interstitial lung disease. The management of these conditions presents a therapeutic challenge, underscoring the need for innovative treatment approaches.ObjectivesTo report the possible role of MAS825, a bispecific anti-IL1β and IL-18 monoclonal antibody, in the treatment of multi-drug-resistant sJIA.MethodsWe report two patients affected by sJIA with severe and refractory MAS and high serum IL-18 levels, responding to dual blockade of IL-1β and IL-18.ResultsThe first patient is a 20-year-old man, presenting a severe MAS complicated by thrombotic microangiopathy, following SARS-CoV-2 infection. He was treated with MAS825, with quick improvement. Eighteen months later, the patient is still undergoing biweekly treatment with MAS825, associated with MTX, ciclosporin and low-dose glucocorticoids, maintaining good control over the systemic features of the disease. The second patient, a 10-year-old girl, presented a severe MAS case, complicated by posterior reversible encephalopathy syndrome, following an otomastoiditis. The MAS was not fully controlled despite treatment with i.v. high-dose glucocorticoids, anakinra and ciclosporin. She began biweekly MAS825, which led to a prompt amelioration of MAS parameters. After 10 months, the patient continues to receive MAS825 and is in complete remission.ConclusionIn light of the pivotal role of IL-1β and IL-18 in sJIA, MAS and interstitial lung disease, MAS825 might represent a possible valid and safe option in the treatment of drug-resistant sJIA, especially in the presence of high serum IL-18 levels.

02 Apr 2024·Rheumatology

Experience of anti-IL-1β and anti-IL-18 combined therapy (MAS825) in recurrent and recalcitrant macrophage activation syndrome

Article

Author: Sözeri, Betül ; Ulu, Kadir ; Çağlayan, Şengül

13 Oct 2023·Clinical and experimental immunology

Efficacy and safety of MAS825 (anti-IL-1β/IL-18) in COVID-19 patients with pneumonia and impaired respiratory function.

Article

Author: O'Neal, Hollis R ; Hakim, Alex D ; Awili, Mustafa ; Yu, Lili ; Junge, Guido ; Overcash, Jeffrey S ; Sengupta, Tirtha ; Jenkins, Janet ; Watts, Jen ; Rowlands, Marianna ; Bendrick-Peart, Jamie ; Stein, Richard R ; Lee, Richard ; Siddiqi, Omar ; Chauffe, Ann ; Matthews, Jesse ; Patel, Bela ; Kiffe, Michael ; Waters, Michael ; Pachori, Alok ; Koo, Philip ; Hammond, Terese C ; Pinck, Anne ; Jaffrani, Naseem ; Levitch, Rafael ; Waldron-Lynch, Frank ; Criner, Gerard J

MAS825, a bispecific IL-1β/IL-18 monoclonal antibody, could improve clinical outcomes in COVID-19 pneumonia by reducing inflammasome-mediated inflammation. Hospitalized non-ventilated patients with COVID-19 pneumonia (n = 138) were randomized (1:1) to receive MAS825 (10 mg/kg single i.v.) or placebo in addition to standard of care (SoC). The primary endpoint was the composite Acute Physiology and Chronic Health Evaluation II (APACHE II) score on Day 15 or on the day of discharge (whichever was earlier) with worst-case imputation for death. Other study endpoints included safety, C-reactive protein (CRP), SARS-CoV-2 presence, and inflammatory markers. On Day 15, the APACHE II score was 14.5 ± 1.87 and 13.5 ± 1.8 in the MAS825 and placebo groups, respectively (P = 0.33). MAS825 + SoC led to 33% relative reduction in intensive care unit (ICU) admissions, ~1 day reduction in ICU stay, reduction in mean duration of oxygen support (13.5 versus 14.3 days), and earlier clearance of virus on Day 15 versus placebo + SoC group. On Day 15, compared with placebo group, patients treated with MAS825 + SoC showed a 51% decrease in CRP levels, 42% lower IL-6 levels, 19% decrease in neutrophil levels, and 16% lower interferon-γ levels, indicative of IL-1β and IL-18 pathway engagement. MAS825 + SoC did not improve APACHE II score in hospitalized patients with severe COVID-19 pneumonia; however, it inhibited relevant clinical and inflammatory pathway biomarkers and resulted in faster virus clearance versus placebo + SoC. MAS825 used in conjunction with SoC was well tolerated. None of the adverse events (AEs) or serious AEs were treatment-related.

100 Deals associated with MAS-825

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autoinflammation With Infantile Enterocolitis	Phase 2	United Kingdom	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	Czechia	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	France	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	Spain	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	United Kingdom	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	Italy	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	United States	Novartis Pharmaceuticals Corp.	18 Dec 2020
Lymphoproliferative Syndrome, X-Linked, 2	Phase 2	Japan	Novartis Pharmaceuticals Corp.	18 Dec 2020
COVID-19	Preclinical	United States	Novartis Pharmaceuticals Corp.	11 Jun 2020
Respiratory Insufficiency	Preclinical	United States	Novartis Pharmaceuticals Corp.	11 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04382651 (MAS825, Pubmed \| Clin Exp Immunol)	Phase 2	Respiratory Insufficiency C-reactive protein (CRP) \| SARS-CoV-2 presence \| inflammatory markers	138	MAS825	wnzgntmgwd(rpxovomcul) = None of the adverse events (AEs) or serious AEs were treatment-related nkmopfgtzz (wzkfuizmmh ) View more	Positive	13 Oct 2023
				Placebo
NCT04382651 (MAS-COVID \| MAS825, CTgov)	Phase 2	COVID-19 \| Respiratory Insufficiency	140	Standard of Care (SoC)+MAS825 (MAS825 + SoC)	epshbsrqeu(nkmxfvdyec) = qvbkzgxoiw ceynsksbmt (hlfpqssqys, doceyzzxlz - vdimyebokb) View more	-	20 Apr 2022
				Placebo (Placebo + SoC)	epshbsrqeu(nkmxfvdyec) = hfiwesjfsd ceynsksbmt (hlfpqssqys, oafzecxkiu - tsomewolnb) View more

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Biosimilar

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