Delving into the Latest Updates on Gimsilumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Gimsilumab (USAN/INN)

+ [1]

Target

GM-CSF

Action

inhibitors

Mechanism

GM-CSF inhibitors(Macrophage colony stimulating factor 2 inhibitors)

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases

Active Indication

Nasopharyngeal Neoplasms

Inactive Indication

Ankylosing SpondylitisCOVID-19Inflammation+ [4]

Originator Organization

Morphotek, Inc.

Active Organization

Morphotek, Inc.

Inactive Organization

Kinevant Sciences GmbH

Roivant Sciences, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 14876812L

Source: *****

Sequence Code 523920135H

Source: *****

This study is intended to treat ankylosing spondylitis (AS). AS is a form of arthritis that primarily affects the spine. It is characterized by inflammation of the spinal joints that can lead to severe pain, and in more advanced cases, ankylosis (sections of the spine fuse in a fixed, immobile position). The study will be an ascending single and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous KIN-1901 in healthy subjects and subjects with AS.

Start Date12 Nov 2019

Sponsor / Collaborator

Kinevant Sciences GmbH

NCT01357759

/ CompletedPhase 1

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis

This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.

Start Date01 May 2013

Sponsor / Collaborator

Morphotek, Inc.

100 Clinical Results associated with Gimsilumab

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100 Translational Medicine associated with Gimsilumab

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100 Patents (Medical) associated with Gimsilumab

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6

Literatures (Medical) associated with Gimsilumab

15 Sep 2022·American Journal of Respiratory and Critical Care Medicine

Erratum: Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial

01 Jun 2022·American Journal of Respiratory and Critical Care Medicine

Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial

Article

Author: Mathews, Kusum S. ; Abbasi, Jamil A. ; DiMaio, J. Michael ; Lyon, George Marshall ; Ahmad, Kareem ; Case, Amy H. ; Sherman, Lisa ; Shen, Steven ; Mendelson, Robert ; Wang, Tisha S. ; Tran, MaryAnn P. ; Gottlieb, Robert L. ; Criner, Gerard J. ; Jeanfreau, Robert ; Spak, Cedric W. ; Bellam, Shashi ; Madduri, Deepu ; Ghamande, Shekhar ; Rice, Todd W. ; Glassberg, Marilyn K. ; Lang, Frederick M. ; Davis, Steven G. ; Lowry, Simon

Rationale: GM-CSF (granulocyte-macrophage colony-stimulating factor) has emerged as a promising target against the hyperactive host immune response associated with coronavirus disease (COVID-19). Objectives: We sought to investigate the efficacy and safety of gimsilumab, an anti-GM-CSF monoclonal antibody, for the treatment of hospitalized patients with elevated inflammatory markers and hypoxemia secondary to COVID-19. Methods: We conducted a 24-week randomized, double-blind, placebo-controlled trial, BREATHE (Better Respiratory Education and Treatment Help Empower), at 21 locations in the United States. Patients were randomized 1:1 to receive two doses of intravenous gimsilumab or placebo 1 week apart. The primary endpoint was all-cause mortality rate at Day 43. Key secondary outcomes were ventilator-free survival rate, ventilator-free days, and time to hospital discharge. Enrollment was halted early for futility based on an interim analysis. Measurements and Main Results: Of the planned 270 patients, 225 were randomized and dosed; 44.9% of patients were Hispanic or Latino. The gimsilumab and placebo groups experienced an all-cause mortality rate at Day 43 of 28.3% and 23.2%, respectively (adjusted difference = 5% vs. placebo; 95% confidence interval [-6 to 17]; P = 0.377). Overall mortality rates at 24 weeks were similar across the treatment arms. The key secondary endpoints demonstrated no significant differences between groups. Despite the high background use of corticosteroids and anticoagulants, adverse events were generally balanced between treatment groups. Conclusions: Gimsilumab did not improve mortality or other key clinical outcomes in patients with COVID-19 pneumonia and evidence of systemic inflammation. The utility of anti-GM-CSF therapy for COVID-19 remains unclear. Clinical trial registered with www.clinicaltrials.gov (NCT04351243).

01 Sep 2021·The Journal of Clinical PharmacologyQ3 · MEDICINE

Therapeutic Application of Corticosteroids in COVID‐19: A Focus on Optimum Dose and Duration of Therapy

Q3 · MEDICINE

Article

Author: Entezari‐Maleki, Taher ; Khiali, Sajad

The pandemic of coronavirus disease 2019 (COVID-19) has resulted in a global health crisis.Pathophysiol., the disease has the initial phase of viral replication that could be followed by an immunol. phase, which is characterized by a systemic inflammatory response, cytokine release syndrome, acute respiratory distress syndrome (ARDS), and multisystem organ dysfunction, and associated with a considerable rate of mortality.The critical condition of the immunol. phase of the disease has raised many studies investigating the efficacy and safety of a series of anti-inflammatory agents, including proinflammatory cytokine inhibitors (anakinra, tocilizumab, sarilumab, adalimumab, infliximab), Janus kinase inhibitors (baricitinib, tofacitinib, ruxolitinib), convalescent plasma, and granulocyte-macrophage colony-stimulating factors (gimsilumab, lenzilumab, namilumab), as well as nonspecific immune modulators such as corticosteroids in patients with COVID-19.It seems that, due to the substantial heterogeneity of the disease, ongoing RCTs should incorporate plans for understanding heterogeneity and identifying patients who are responsive to corticosteroids and appropriate dose of the medicines considering the burden of lung injury, inflammatory markers such as neutrophil-to-lymphocyte ratio, sedimentation rate, levels of interleukins, presence of poor prognosis risk factors, and other clin. and paraclin. data.Finally, the pharmacokinetics, glucocorticoids/mineralocorticoids ratios, and equivalent doses of corticosteroids, as well as dose and duration of the drugs in similar situations like the classic ARDS, should be considered in the clin. trials and treatment centers.

1

News (Medical) associated with Gimsilumab

18 Jun 2021

·www.globenewswire.com

Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight

Los Angeles, June 17, 2021 (GLOBE NEWSWIRE) -- Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight The report offers the most up-to-date information on Axial Spondyloarthritis pipeline products being developed by notable companies such as Pfizer, Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, FunPep Co Ltd., Kinevant Sciences, Izana Bioscience, Mycenax Biotech, and UCB Biopharma, among others. DelveInsight’s ‘Axial Spondyloarthritis (axSpA) Pipeline Insights’ report offers exhaustive coverage of the emerging therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the important takeaways from the Axial Spondyloarthritis Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Axial Spondyloarthritis Emerging Therapies and Forecast The Axial Spondyloarthritis Pipeline reports lay down a thorough coverage of the ongoing clinical trials, collaborations taking place in the domain, recent happenings in the Axial Spondyloarthritis pipeline space, and growth prospects across the Axial Spondyloarthritis domain. Axial Spondyloarthritis: Overview Axial Spondyloarthritis is a chronic, inflammatory rheumatic disease that affects primarily the axial joints leading to severe pain, stiffness, and fatigue. It starts with an early inflammatory phase in which there is no structural damage in the sacroiliac joints (non-radiographic disease) progressing to later stages in which structural damage is visible on X‑ray scans of the sacroiliac joints as erosions, sclerosis, or bony bridges (radiographic disease; also known as Ankylosing Spondylitis). Discover more about the disease, treatments, and pipeline therapies @ axSpA Pipeline Assessment Axial Spondyloarthritis Pipeline Drugs Request for Sample to know more @ Axial Spondyloarthritis Pipeline Analysis, Key Companies, and Futuristic Trends Axial Spondyloarthritis Therapeutics Assessment The Axial Spondyloarthritis Pipeline report presents a kaleidoscopic view of the axSpA emerging novel therapies segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit Axial Spondyloarthritis Pipeline: Emerging Novel Therapies Scope of the Axial Spondyloarthritis Pipeline Report Coverage: GlobalKey Players: Izana Bioscience, UCB, Sun Pharma Global, Akeso Biopharma, Kinevant Sciences, Jiangsu Hengrui Medicine Co., Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, Mycenax Biotech, Boehringer Ingelheim, and Qyuns Therapeutics among others.Key Axial Spondyloarthritis Pipeline Therapies: Namilumab , Bimekizumab, Tofacitinib, Tildrakizumab, AK-111, NDI 031232, Gimsilumab, QX002N, SHR-0302, Jaktinib, SCB-808, FPP003, KIN-1901, ENIA11, BI 730357, and QX002N among others. Discover more about the report offerings @ axSpA Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Get in touch with our Business executive for Regulatory Analysis, Licensing Services, and Consulting Solutions Related Reports Axial Spondyloarthritis MarketDelveInsight's "Axial Spondyloarthritis Market Insights, Epidemiology, and Market Forecast-2030" report. Non-Radiographic Axial Spondyloarthritis MarketDelveInsight's "Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) Market Insights, Epidemiology, and Market Forecast-2030" report. Spondylolisthesis Market InsightsDelveInsight's “Spondylolisthesis Market Insights, Epidemiology, and Market Forecast-2030" report. Ankylosing Spondylitis MarketDelveInsight’s ‘Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast–2030’ report. Global Kinase Inhibitor In Autoimmune Diseases MarketDelveInsight’s ‘Global Kinase Inhibitor in Autoimmune Diseases Market Insights and Market Forecast – 2030’ report. Adenosine Deaminase Severe Combined Immunodeficiency MarketDelveInsight's "Adenosine Deaminase-Severe Combined Immunodeficiency Market Insights, Epidemiology, and Market Forecast-2030" report. Adult-Onset Still Disease MarketDelveInsight’s “Adult-onset Still’s Disease Market Insights, Epidemiology, and Market Forecast – 2030” report. Browse through our posts ABSSSI Pipeline Analysis Parkinson's Disease Risk FactorsWearable Healthcare Devices Market About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

Collaborate

100 Deals associated with Gimsilumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11121	-	-	DB15280

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nasopharyngeal Neoplasms	Phase 2	-	Morphotek, Inc.	-
COVID-19	Discovery	United States	Roivant Sciences, Inc.	15 Apr 2020
COVID-19	Discovery	United States	Kinevant Sciences GmbH	15 Apr 2020
Lung Injury	Discovery	United States	Kinevant Sciences GmbH	15 Apr 2020
Lung Injury	Discovery	United States	Roivant Sciences, Inc.	15 Apr 2020
Respiratory Distress Syndrome, Adult	Discovery	United States	Roivant Sciences, Inc.	15 Apr 2020
Respiratory Distress Syndrome, Adult	Discovery	United States	Kinevant Sciences GmbH	15 Apr 2020
Inflammation	Discovery	Canada	Kinevant Sciences GmbH	12 Nov 2019
Rheumatoid Arthritis	Discovery	United States	Morphotek, Inc.	01 May 2013
Rheumatoid Arthritis	Discovery	Netherlands	Morphotek, Inc.	01 May 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04351243 (Pubmed \| Am J Respir Crit Care Med) Manual	Phase 2	COVID-19	225	Gimsilumab	(fytbwhmijx) = avantsdbzf pmvcmrldfd (digefteczg )	Negative	15 Mar 2022
				Placebo	(fytbwhmijx) = dnplktgsew pmvcmrldfd (digefteczg )
NCT04351243 (BREATHE, CTgov)	Phase 2	COVID-19 \| Respiratory Distress Syndrome, Adult \| Lung Injury	227	Gimsilumab (Gimsilumab)	dwvpkcxplu(duibwmnxon) = iauigzpyih xgwibopode (scvvtnjhaw, vvtwfonpal - xhdplspvjh) View more	-	10 Dec 2021
				Placebo (Placebo)	dwvpkcxplu(duibwmnxon) = iuvgtwvlyh xgwibopode (scvvtnjhaw, bieicuuopp - wotmceymdk) View more
NCT01357759 (Biospace) Manual	Phase 1	Rheumatoid Arthritis	51	MORAb-022-001	(qnivdjgrhm) = hsonhsfjpu hwoafrrmpv (uuczytlznp ) View more	Positive	07 Dec 2015

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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