GSK2330811 / GSK - LARVOL DELTA

Predicting the Long-Term Effects of Therapeutic Neutralization of Oncostatin M on Human Hematopoiesis. (PubMed, Clin Pharmacol Ther) - "We utilized clinical data from studies of an anti-OSM monoclonal antibody (GSK2330811) in healthy volunteers (n = 49) and systemic sclerosis patients (n = 35), to quantitatively determine the link between OSM and alterations in red blood cell (RBC) and platelet production...Individual extent of RBC precursor modulation was moderately correlated to skin mRNA gene expression changes. The physiological basis and consideration of interplay among hematopoietic variables makes the model generalizable to other drug and nondrug scenarios, with adaptations for patient populations, diseases, and therapeutics that modulate hematopoiesis or exhibit risk of anemia and/or thrombocytopenia."

Journal • Fibrosis • Hematological Disorders • Immunology • Scleroderma • Systemic Sclerosis • Thrombocytopenia

Biological and clinical insights from a randomised phase II study of an anti-oncostatin M monoclonal antibody in systemic sclerosis. (PubMed, Rheumatology (Oxford)) - P2 | "Despite a robust and novel experimental medicine approach and evidence of target engagement, anticipated SSc-related biologic effects of GSK2330811 were not different from placebo and safety was unfavourable, suggesting OSM inhibition may not be a useful therapeutic strategy in SSc."

Journal • P2 data • Fibrosis • Immunology • Inflammation • Scleroderma • Systemic Sclerosis

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese and Caucasian Participants (clinicaltrials.gov) - P1; N=9; Completed; Sponsor: GlaxoSmithKline; Suspended ➔ Completed; N=50 ➔ 9; Trial completion date: Mar 2022 ➔ May 2020; Trial primary completion date: Mar 2022 ➔ May 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date

COSMIS: Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease (clinicaltrials.gov) - P2a/2b; N=0; Withdrawn; Sponsor: GlaxoSmithKline; N=280 ➔ 0; Trial completion date: Dec 2024 ➔ May 2025; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Nov 2023 ➔ Apr 2024

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese and Caucasian Participants (clinicaltrials.gov) - P1; N=50; Suspended; Sponsor: GlaxoSmithKline; Trial completion date: Nov 2021 ➔ Mar 2022; Trial primary completion date: Nov 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese and Caucasian Participants (clinicaltrials.gov) - P1; N=50; Suspended; Sponsor: GlaxoSmithKline; N=10 ➔ 50

Clinical • Enrollment change

Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - P2; N=35; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

GSK2330811: Data from P2 trial (NCT03041025) for SSc in H1 2020 (GSK) - Q2 2018 Results

P2 data • Immunology • Systemic Sclerosis

Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: GlaxoSmithKline

New P2 trial • Biosimilar • Fibrosis • Immunology • Systemic Sclerosis

GSK: Q2 FY 2016 Results (GSK) - Anticipated initiation of proof-of-concept study in systemic sclerosis in H1 2017

Anticipated new trial • Systemic Sclerosis

COSMIS: Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease (clinicaltrials.gov) - P2a/2b; N=280; Not yet recruiting; Sponsor: GlaxoSmithKline; Trial completion date: May 2024 ➔ Dec 2024; Initiation date: Jun 2020 ➔ Jan 2021; Trial primary completion date: Apr 2023 ➔ Nov 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • CRP

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=10; Suspended; Sponsor: GlaxoSmithKline; Trial completion date: Dec 2020 ➔ Nov 2021; Trial primary completion date: Dec 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=10; Suspended; Sponsor: GlaxoSmithKline; Trial completion date: Jul 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - P2; N=35; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

COSMIS: Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease (clinicaltrials.gov) - P2a/2b; N=280; Not yet recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Feb 2024 ➔ May 2024; Initiation date: Mar 2020 ➔ Jun 2020; Trial primary completion date: Jan 2023 ➔ Apr 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • CRP

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=10; Suspended; Sponsor: GlaxoSmithKline; Recruiting ➔ Suspended

Clinical • Trial suspension

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

GSK2330811: Proof-of-concept data from P2 trial (NCT03041025) for diffuse cutaneous systemic sclerosis in H2 2020 (GSK) - Q3 2019 Results

P2 data

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: GlaxoSmithKline

Clinical • New P1 trial

In vivo affinity and target engagement in skin and blood in a first-time-in-human study of an anti-oncostatin M monoclonal antibody. (PubMed, Br J Clin Pharmacol) - P1; "Single subcutaneous doses of GSK2330811 were well tolerated in healthy subjects. GSK2330811 demonstrated sufficient affinity to achieve target engagement in systemic circulation and target skin tissue, supporting progression of GSK2330811 clinical development."

Journal • Preclinical

Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Feb 2020 ➔ Jun 2020; Trial primary completion date: Feb 2020 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date

GSK2330811: Proof-of-concept data from P2 trial (NCT03041025) for diffuse cutaneous systemic sclerosis in H1 2020 (GSK) - Q4 2018 Results

P2 data

Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: GlaxoSmithKline; Phase classification: P1/2 ➔ P2; Trial completion date: Sep 2019 ➔ Jan 2020; Trial primary completion date: Sep 2019 ➔ Jan 2020

Clinical • Phase classification • Trial completion date • Trial primary completion date