leramistat (MBS2320) / Istesso, J&J - LARVOL DELTA

A Study to Investigate Leramistat in Patients With IPF (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Modern Biosciences Ltd | N=150 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Portfolio company Istesso provides update on Phase 2b study of leramistat in rheumatoid arthritis (IP Group) - P2b | N=249 | NCT05460832 | Sponsor: Modern Biosciences Ltd | "The leramistat phase 2b study was a 12-week randomised, double-blind, placebo-controlled trial in adults with moderate-severe RA...Although the study did not meet the primary endpoint of improvements in ACR20 versus placebo, leramistat did demonstrate statistically significant reductions in the key secondary endpoint of bone erosions, as well as improvements in disability and fatigue...Istesso highlighted that these findings demonstrate leramistat’s unique mechanism of action (MOA) and support further evaluation of its potential to promote adaptive tissue repair in combination with existing disease-modifying anti-rheumatic drugs (DMARDs) in RA, as well as in other chronic conditions....No new safety concerns were identified in the study....Istesso will publish full study results in due course and plans further Phase 2 studies to evaluate leramistat’s..."

P2b data • Rheumatoid Arthritis

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Modern Biosciences Ltd | N=36 ➔ 48 | Trial primary completion date: May 2024 ➔ Sep 2024

Enrollment change • Trial primary completion date

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Modern Biosciences Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Modern Biosciences Ltd

New P1 trial

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA (clinicaltrials.gov) - P2 | N=249 | Completed | Sponsor: Modern Biosciences Ltd | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA (clinicaltrials.gov) - P2 | N=249 | Active, not recruiting | Sponsor: Modern Biosciences Ltd | Phase classification: P2b ➔ P2

Phase classification • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

A Study to Investigate Leramistat in Patients With IPF (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Modern Biosciences Ltd

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CRP

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA (clinicaltrials.gov) - P2b | N=249 | Active, not recruiting | Sponsor: Modern Biosciences Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

A Study to Investigate MBS2320 in Patients With IPF (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Modern Biosciences Ltd

New P2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

IP Group: Portfolio Company Istesso's MBS2320 Gets FDA Fast Track And Orphan Drug Designation (Nasdaq) - "IP Group plc...a developer of science and technology businesses, Monday noted that its portfolio company Istesso Ltd.'s investigational metabolic reprogramming agent, MBS232, has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration or FDA. The designation has been received for the treatment of patients with idiopathic pulmonary fibrosis or IPF....Istesso, an immunometabolism drug discovery and development company, will start a clinical study in patients with IPF in 2023."

Fast track designation • New trial • Orphan drug • Idiopathic Pulmonary Fibrosis

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA (clinicaltrials.gov) - P2b | N=224 | Recruiting | Sponsor: Modern Biosciences Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Dose-Ranging Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA (clinicaltrials.gov) - P2b | N=224 | Not yet recruiting | Sponsor: Modern Biosciences Ltd

New P2b trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

A 12-week study of a new treatment, MBS2320, in Patients with Rheumatoid Arthritis Taking Methotrexate (clinicaltrialsregister.eu) - P2 | N=108 | Completed | Sponsor: Modern Biosciences plc

New P2 trial • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Rheumatoid Arthritis • Rheumatology • CRP

"Rheumatologe: MBS2320 at the EULAR 2020 Online Meeting https://t.co/jLo1QtrMiw #RA #rheumatoidarthritis #eular2020 #eular2020goesvirtual" (@Rheumatologe)

Immunology • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] MBS2320, A NOVEL SELECTIVE MODULATOR OF IMMUNE METABOLISM, IN PATIENTS WITH SEVERE RHEUMATOID ARTHRITIS: SAFETY, TOLERABILITY AND EFFICACY RESULTS OF A PHASE 2 STUDY (EULAR 2020) - "Objectives: To evaluate the safety, tolerability and efficacy of MBS2320 in patients receiving a stable dose of methotrexate (MTX). MBS2320 was generally well tolerated for up to 12 weeks in this RA study population. Nausea was the most common TEAE, was generally mild in severity and resolved without treatment. In this population of patients with hard-to-treat, severe, active, erosive disease MBS2320 showed evidence of a clinical benefit on both ACR20 responses and DAS28-CRP."

Clinical • P2 data • Fatigue • Gastrointestinal Disorder • Immunology • Pain • Rheumatoid Arthritis • Rheumatology

Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2a; N=121; Completed; Sponsor: Modern Biosciences plc; Active, not recruiting ➔ Completed

Clinical • Trial completion

A FIRST-IN-CLASS METABOLIC REPROGRAMMING AGENT, MBS2320, SELECTIVELY MODULATES IMMUNE CELL FUNCTION AND IMPROVES OSTEOID FORMATION AND BONE PROTECTION VERSUS ETANERCEPT IN THE MOUSE COLLAGEN-INDUCED ARTHRITIS MODEL (EULAR 2019) - "MBS2320 selectively inhibits myeloid and lymphoid activity/differentiation, whilst sparing mesenchymal cells, in vitro. In murine CIA, MBS2320 treatment led to the formation of anatomically appropriate osteoid layering indicating an ongoing process of osteogenesis conditioned by biomechanics. By contrast osteoid formation due to etanercept was more ‘reactive’ and secondary to suppression of inflammation."

Preclinical

SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MBS2320, A SELECTIVE MODULATOR OF IMMUNE METABOLISM, IN HEALTHY VOLUNTEERS AND PATIENTS WITH RHEUMATOID ARTHRITIS (EULAR 2019) - "Objectives: To investigate the safety, tolerability and pharmacokinetics of MBS2320 in healthy volunteers and patients with Rheumatoid Arthritis (RA) receiving a stable dose of methotrexate (MTX). MBS2320 was well tolerated for up to 14 days when administered to healthy volunteers and to patients with RA receiving MTX. Systemic exposure was dose-proportional with no evidence of a pharmacokinetic interaction with MTX. Evaluation of biomarkers of bone turnover and inflammation in RA patients showed changes consistent with those expected of an agent with the potential to directly protect the bone and simultaneously ameliorate inflammation."

Clinical • PK/PD data