MTX-463 / Mediar Therap, Eli Lilly - LARVOL DELTA

Late Breaking Abstract - A Phase 1 trial to evaluate the safety, PK and target engagement of MTX-463, a monoclonal antibody inhibitor of WISP1 (ERS 2025) - "Inhibition of WISP1 reduces fibrosis in the bleomycin lung model. MTX-463 appears to be safe and well tolerated with linear PK, a long T1/2 and low ADA. It successfully engaged WISP1 at all doses evaluated."

Clinical • Late-breaking abstract • P1 data • Fibrosis • Immunology

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-463-I201: WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=164 | Recruiting | Sponsor: Mediar Therapeutics

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

MTX-463-I101: A First-in-Human Safety Trial of MTX-463 (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Mediar Therapeutics | Recruiting ➔ Completed

Trial completion • IFNG • IL10 • IL17A • IL1B • IL2 • IL4 • IL6 • TNFA

Mediar Therapeutics Enters into Global Licensing Agreement with Lilly to Advance First-in-Class WISP1 Antibody for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) (PRNewswire) - "Mediar Therapeutics, Inc...announced a global licensing agreement with Eli Lilly and Company to advance MTX-463 into a Phase 2 clinical trial for idiopathic pulmonary fibrosis (IPF)...Following completion of the Phase 2 study, Lilly will have the right to lead all further clinical development and commercialization of the program...Under the terms of the agreement Mediar will receive a combined $99 million, which is inclusive of an upfront payment and near-term milestones. Mediar may receive up to an additional $687 million in potential downstream development and commercialization milestones. Additionally, Mediar is eligible to receive high-single to low-double digit royalty payments and net sales milestones based on potential future product sales...Mediar's third novel fibrosis program, targeting SMOC2, is also advancing with a plan to nominate a clinical candidate in the first half of 2025...Mediar expects to initiate a Phase 2 study in IPF with MTX-463 in 1H-2025."

Licensing / partnership • New molecule • New P2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis

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

Anti-WISP1 (MTX-463) as a Novel Potential Therapy for Idiopathic Pulmonary Fibrosis (ATS 2024) - "C57BL/6 mice were administered intratracheal bleomycin on day 0, followed by therapeutic anti-WISP1 blocking antibody treatment from day 7 to day 21 post-bleomycin. Treatment with an anti-WISP1 monoclonal antibody significantly reduced fibrosis in vitro and in preclinical mouse models. These findings highlight the significance of WISP1 as a pro-fibrotic factor and supports the potential of MTX-463 as a therapy for IPF."

Late-breaking abstract • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • IL6 • TIMP1

MTX-463-I101: A First-in-Human Safety Trial of MTX-463 (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Mediar Therapeutics

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

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

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...today 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 newly appointed members of the clinical advisory board are...Flavia Castelino...Scott Friedman, Robert Lafyatis...Toby Maher...John Varga. In addition, new preclinical data supporting the application of MTX-463 in IPF will be presented at the 2024 American Thoracic Society (ATS) meeting in San Diego, May 17-22, 2024. 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."

Announcement • Regulatory • Scleroderma • Systemic Sclerosis