Mediar Therapeutics, Inc., a biotechnology company focused on developing first-in-class therapies to halt fibrosis progression, has announced the dosing of the first cohort in a Phase 1 trial for MTX-463. This follows the FDA's clearance of the investigational new drug (IND) application for MTX-463, a human IgG1 antibody designed to neutralize WISP-1-mediated fibrotic signaling, targeting Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases.
The Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of MTX-463 at multiple dose levels, while also assessing its ability to engage its target, WISP-1. The trial involves healthy participants and includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
Mediar's Chief Executive Officer, Rahul Ballal, Ph.D., highlighted the significance of advancing the first-in-class portfolio to the clinic, marking a milestone for the company. Mediar also plans to initiate a Phase 1 study for its second program, MTX-474, an anti-EphrinB2 molecule, in the third quarter of 2024.
To support the clinical development of its pipeline, Mediar has established a Clinical Advisory Board (CAB) comprising renowned experts in fibrosis across various medical fields. The CAB includes leaders from prestigious institutions such as Harvard Medical School, the Icahn School of Medicine at Mount Sinai, and the University of California San Diego, among others.
New preclinical data on MTX-463's application in IPF will be presented at the 2024 American Thoracic Society (ATS) meeting, while data supporting MTX-474 in Systemic Sclerosis (SSc) will be showcased at the Congress on the EPH/Ephrin System in Italy.
MTX-463 targets WISP-1, a protein implicated in fibrosis progression, with initial data showing its potential to significantly reduce fibrosis in preclinical models. MTX-474, on the other hand, is designed to neutralize EphrinB2 signaling, which plays a role in the fibrosis of the skin, lungs, and heart. Both antibodies represent Mediar's innovative approach to fibrosis treatment, focusing on the myofibroblast, the key pathogenic cell in fibrosis.
