MTX-474 / Mediar Therap - LARVOL DELTA

Mediar selects Qureight to support systemic sclerosis trial (Drug Discovery World) - "Qureight’s AI 3D quantitative imaging analytics platform and services will be used to support Mediar’s Phase II EncompaSSc clinical trial. The trial will evaluate MTX-474, a monoclonal antibody therapeutic for people with diffuse cutaneous systemic sclerosis (dcSSc)...During the trial, Qureight will use its platform to analyse High-Resolution Computed Tomography (HRCT) images taken of participants’ lungs at screening, and later at 24 weeks after treatment with MTX-474. Using precise quantitative imaging analytics of compartment-specific lung biomarkers, Qureight aims to provide a comprehensive view of changes within the lungs."

Trial status • Systemic Sclerosis

EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc) (clinicaltrials.gov) - P2 | N=85 | Recruiting | Sponsor: Mediar Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Scleroderma • Systemic Sclerosis

MTX-474 APPEARS SAFE AND WELL TOLERATED, ENGAGES ITS TARGET, EPHRINB2, AND IMPACTS PHARMACODYNAMIC BIOMARKERS IN HEALTHY VOLUNTEERS (SSWC 2026) - "MTX-474 appears to be safe and well tolerated with low immunogenicity. It successfully engages it's target, EphrinB2, and produces a trend toward a reduction in biomarkers associated with fibrosis and inflammation, with the reduced levels of these markers only occurring with doses that completely suppress free EphrinB2 levels."

Biomarker • Clinical • First-in-human • PK/PD data • Fibrosis • Immunology • Inflammation • Scleroderma • Systemic Sclerosis • IL6

Mediar Therapeutics Announces Oversubscribed $76 Million Series B Financing and Clinical Advancement of First-in-Class Fibrosis Portfolio (Yahoo Finance) - "Proceeds from the financing will further support advancement of Mediar's wholly owned assets, including MTX-474, an antagonist of EphrinB2, being studied in a Phase 2a study in patients with systemic sclerosis (SSc), and MTX-439, a SMOC2 antagonist, proceeding to Phase 1 studies for the treatment of chronic kidney disease (CKD) associated fibrosis....The company has initiated the EncompaSSc trial, a randomized, double-blinded, placebo-controlled 24-week Phase 2a study designed to evaluate the efficacy, safety, and tolerability of MTX-474 in approximately 90 patients living with SSc, using the validated mRSS (Modified Rodnan Skin Score) tool, as the primary endpoint."

Financing • Trial status • Chronic Kidney Disease • Fibrosis • Systemic Sclerosis

EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc) (clinicaltrials.gov) - P2 | N=85 | Not yet recruiting | Sponsor: Mediar Therapeutics

New P2 trial • Immunology • Scleroderma • Systemic Sclerosis

Mediar Therapeutics Doses First Patient in Phase 2 WISPer Trial of MTX-463 for Idiopathic Pulmonary Fibrosis (PRNewswire) - "Mediar Therapeutics, Inc...announced the first patient has been dosed in its Phase 2 WISPer clinical trial evaluating MTX-463, an investigational therapy for idiopathic pulmonary fibrosis (IPF)....Mediar anticipates initiating a Phase 2 trial for MTX-474 in systemic sclerosis in the second half of 2025."

New P2 trial • Trial status • Idiopathic Pulmonary Fibrosis • Systemic Sclerosis

MTX-474-S101: A First-in-Human Safety Trial of MTX-474 (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Mediar Therapeutics | Recruiting ➔ Completed

Trial completion

MTX-474 (PRNewswire) - "Mediar expects to initiate a Phase 2 study in SSc with MTX-474 in 2H-2025."

New P2 trial • Immunology • Systemic Sclerosis

Mediar Therapeutics Initiates Second Clinical Program in Portfolio of Novel First-In-Class Antibodies Designed to Halt Fibrosis (PRNewswire) - "Mediar Therapeutics, Inc...announced the first cohort of participants has been dosed in a Phase 1 trial evaluating the safety and tolerability of MTX-474, a human IgG1 antibody designed to neutralize EphrinB2 signaling. The study, taking place in Australia, is designed to assess the safety, tolerability, pharmacokinetics, and target engagement of MTX-474 in healthy participants through staggered single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The company also reports continued progress in its US Phase 1 study of its WISP1 targeting antibody, MTX-463, with approximately three quarters of the cohorts dosed, and completion of the trial expected by the end of 2024. Additionally, MTX-463 was granted orphan drug and fast track designations by the FDA, underscoring the potential of WISP1 to address significant unmet needs in treating rare fibrotic diseases, including Idiopathic Pulmonary Fibrosis (IPF)."

Fast track • Orphan drug • Trial status • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Scleroderma • Systemic Sclerosis

A First-in-Human Safety Trial of MTX-474 (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Mediar Therapeutics

New P1 trial • IFNG • IL10 • IL17A • IL1B • IL2 • IL4 • IL6 • TNFA

A First-in-Human Safety Trial of MTX-474 (ANZCTR) - P1 | N=80 | Not yet recruiting | Sponsor: Mediar Therapeutics

New P1 trial • Immunology • Scleroderma • Systemic Sclerosis

Mediar Advances First-in-Class Fibrosis Portfolio to the Clinic with First Cohort Dosing in Phase 1 trial of MTX-463 and Establishes Clinical Advisory Board (PRNewswire) - "Mediar Therapeutics, Inc...announced that, following FDA clearance of its investigational new drug (IND) application, the first cohort of participants has been dosed in a Phase 1 trial evaluating the safety and tolerability of MTX-463. MTX-463 is a first-in-class human IgG1 antibody designed to neutralize WISP-1-mediated fibrotic signaling to address IPF and other fibrotic diseases. The Phase 1 study for MTX-463 is designed to assess its safety at multiple dose levels, tolerability, and pharmacokinetics, while also assessing the ability of MTX-463 to engage its target, WISP-1. The trial is enrolling healthy participants and consists of staggered single ascending dose (SAD) and multiple ascending dose (MAD) cohorts....Data supporting MTX-474 in Systemic Sclerosis (SSc) will be presented in an oral presentation at the Congress on the EPH/Ephrin System in Parma, Italy, May 16-17, 2024."

IND • Preclinical • Trial status • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Systemic Sclerosis