MTX-474 / Mediar Therap - LARVOL DELTA

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