namilumab (IZN-101) / Amgen, Takeda, Izana Biosci, Roivant - LARVOL DELTA

RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=107 | Terminated | Sponsor: Kinevant Sciences GmbH | Active, not recruiting ➔ Terminated; Sponsor Decision

Trial termination • Immunology • Respiratory Diseases • Sarcoidosis

Kinevant Sciences Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis (GlobeNewswire) - "Kinevant Sciences...announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered once-monthly as a subcutaneous injection, in participants with chronic active pulmonary sarcoidosis....With these results, Kinevant will be discontinuing further development of namilumab for the treatment of sarcoidosis. Kinevant is committed to publishing the results of RESOLVE-Lung to inform future sarcoidosis research."

Discontinued • P2 data • Immunology • Sarcoidosis

MT203. Advanced Cardiac Life Support for the Perioperative Setting: PeRLS (Non-CME) (ASA 2024) - "DESCRIPTION Find out how PeRLS can save time and better prepare care teams for the crises they're more likely to encounter in the OR. Designed as an alternative to ACLS, PeRLS goes beyond the basic skills anesthesia professoinals use every day to emphasize critical thinking in high-impact scenarios."

Metastases • Anesthesia

RESOLVE-LUNG, a multinational, randomized, placebo-controlled Phase II trial of namilumab, an anti-GMCSF monoclonal antibody, in chronic pulmonary sarcoidosis: trial design and patient characteristics (ERS 2024) - P2 | " The majority of patients enrolled were above 50 years of age, male, Caucasian, and treated with OCS and/or IST, with methotrexate being the most commonly used IST. RESOLVE-LUNG, one of the largest Phase II trials in chronic sarcoidosis aims to investigate the efficacy and safety profile of namilumab in chronic pulmonary sarcoidosis."

Clinical • P2 data • Immunology • Pulmonary Disease • Respiratory Diseases • Sarcoidosis • CSF2

Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial. (PubMed, Lancet Rheumatol) - P2a | "Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated."

Journal • P2 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CSF2

RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=107 | Active, not recruiting | Sponsor: Kinevant Sciences GmbH | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: May 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Respiratory Diseases • Sarcoidosis

RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Kinevant Sciences GmbH | Phase classification: P2a ➔ P2

Phase classification • Immunology • Sarcoidosis

"First patient in the UK randomised and dosed with Namilumab for sarcoidosis at @KingsCollegeNHS @KingsCRF @kinevant @SarcoidosisUK @drjamesgalloway" (@ds_nagra)

Clinical • Immunology • Sarcoidosis

RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - P2a | N=1 | Terminated | Sponsor: Kinevant Sciences GmbH | N=30 ➔ 1 | Trial completion date: Jan 2024 ➔ Nov 2022 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Nov 2022; Sponsor business decision not related to safety

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Immunology • Sarcoidosis

Kinevant Sciences Announces First Patient Dosed in Phase 2 Study of Namilumab for the Treatment of Pulmonary Sarcoidosis (RESOLVE-Lung) (BioSpace) - "Kinevant Sciences...announced that the first patient has been dosed in its RESOLVE-Lung study. This Phase 2 clinical study will evaluate the efficacy and safety of Kinevant’s namilumab for the treatment of pulmonary sarcoidosis. Namilumab is a human monoclonal antibody that targets granulocyte-macrophage colony stimulating factor (GM-CSF), one of the key cytokines believed to be responsible for granuloma formation and persistence in sarcoidosis."

Trial status • Immunology • Sarcoidosis

Roivant Sciences Reports Financial Results for the Second Quarter Ended September 30, 2022 and Provides Business Update (GlobeNewswire) - "Plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024."

P2 data • Immunology • Sarcoidosis

RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - P2a | N=30 | Recruiting | Sponsor: Kinevant Sciences GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Sarcoidosis

Roivant Sciences Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2022 and Provides Business Update (GlobeNewswire) - "Roivant Sciences Ltd...today reported its financial results for the fourth quarter and fiscal year ended March 31, 2022 and provided an update on the Company’s operations....Kinevant initiated a Phase 2 trial evaluating namilumab for the treatment of sarcoidosis....Kinevant expects to report topline data from the ongoing Phase 2 clinical trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024."

P2 data • Trial status • Immunology • Sarcoidosis

RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: Kinevant Sciences GmbH | Initiation date: Apr 2022 ➔ Jun 2022

Trial initiation date • Immunology • Sarcoidosis

RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Kinevant Sciences GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Respiratory Diseases • Sarcoidosis

RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Kinevant Sciences GmbH | Trial completion date: Jul 2024 ➔ Jan 2025 | Trial primary completion date: Nov 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Immunology • Respiratory Diseases • Sarcoidosis

RESOLVE-Heart: A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: Kinevant Sciences GmbH

New P2a trial • Immunology • Sarcoidosis

RESOLVE-Lung: A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Kinevant Sciences GmbH

New P2 trial • Immunology • Respiratory Diseases • Sarcoidosis

Roivant Sciences Reports Financial Results for the Quarter Ended December 31, 2021 and Provides Business Update (GlobeNewswire) - "Roivant Sciences Ltd...today reported its financial results for the third fiscal quarter ended December 31, 2021 and provided an update on the Company’s operations....The FDA cleared the IND submitted by Kinevant for a Phase 2 trial evaluating namilumab for the treatment of sarcoidosis....Kinevant remains on track to initiate its Phase 2 trial evaluating namilumab for the treatment of sarcoidosis in the first half of calendar year 2022."

IND • New P2 trial • Immunology

Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial. (PubMed, Lancet Respir Med) - "Namilumab, but not infliximab, showed proof-of-concept evidence for reduction in inflammation-as measured by CRP concentration-in hospitalised patients with COVID-19 pneumonia. Namilumab should be prioritised for further investigation in COVID-19."

Clinical • Journal • P2 data • Critical care • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • CRP

Pharmaco-Immunomodulatory Therapy in COVID-19. (PubMed, Drugs) - "Specific immune modulators include anti-cytokines such as interleukin (IL)-1 and IL-6 receptor antagonists (e.g. anakinra, tocilizumab, sarilumab, siltuximab), Janus kinase (JAK) inhibitors (e.g. baricitinib, ruxolitinib), anti-tumor necrosis factor-α (e.g. adalimumab, infliximab), granulocyte-macrophage colony-stimulating factors (e.g. gimsilumab, lenzilumab, namilumab), and convalescent plasma, with promising to negative trials and other data. Non-specific immune modulators include human immunoglobulin, corticosteroids such as dexamethasone, interferons, statins, angiotensin pathway modulators, macrolides (e.g. azithromycin, clarithromycin), hydroxychloroquine and chloroquine, colchicine, and prostaglandin D2 modulators such as ramatroban...Research efforts should focus not only on the most relevant immunomodulatory strategies but also on the optimal timing of such interventions to maximize therapeutic outcomes. In this review, we discuss the potential role and safety..."

Journal • Review • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease

Targeting Granulocyte-Monocyte Colony-Stimulating Factor Signaling in Rheumatoid Arthritis: Future Prospects. (PubMed, Drugs) - "Mainly because of this reason, nowadays the development program of most GM-CSF blockers for RA has been discontinued, with the exception of otilimab, which is under evaluation in two phase III RCTs with a head-to head non-inferiority design against tofacitinib...Phase II trials are ongoing with the aim of evaluating mavrilimumab for the treatment of giant cell arteritis, and namilumab for the treatment of spondyloarthritis...This review aims to describe in detail the available evidence on the GM-CSF blocking pathway in RA management, paving the way to a possible alternative treatment for RA patients. Novel insights regarding the potential use of GM-CSF blockers for alternative indications will be also addressed."

Journal • Review • Ankylosing Spondylitis • Giant Cell Arteritis • Immune Modulation • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatoid Arthritis • Rheumatology • Scleroderma • Spondylarthritis • Systemic Sclerosis

First drugs announced in major Covid-19 drugs trial (University of Birmingham) - "Two UK drugs companies will be the first to partner with the Universities of Birmingham and Oxford as part of a major new UK drugs trial to test potential therapeutics to treat patients hospitalised with COVID-19....Namilumab (IZN-101) is a fully human monoclonal antibody....It targets a ‘cytokine’ called GM-CSF (granulocyte-macrophage colony stimulating factor)....The second drug, Infliximab (CT-P13) developed by Slough based Celltrion Healthcare UK, is an anti-tumour necrosis factor (TNF) therapy..."

Cytokine storm • Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

GM-CSF as a therapeutic target in psoriasis: randomised, controlled investigation using namilumab - a specific, human anti-GM-CSF monoclonal antibody. (PubMed, Br J Dermatol) - P2 | "GM-CSF blockade is not critical for suppression of key inflammatory pathways underlying psoriasis (NCT02129777)."

Clinical • Journal • Dermatology • Dermatopathology • Immunology • Psoriasis

Izana Bioscience initiates namilumab phase II proof-of-concept clinical study in ankylosing spondylitis (PRNewswire) - P2, N=40; NAMASTE (NCT03622658); Sponsor: Izana Biosicence; "Izana Bioscience...announced the initiation of a phase II proof-of-concept clinical study of namilumab in ankylosing spondylitis...Study results are expected in early 2019."

P2 data • Trial initiation date • Ankylosing Spondylitis • Immunology • Inflammation