Mediar Commences Patient dosing in US FDA Approved Phase 1 Trial

Mediar Therapeutics, Inc., a biotechnology company developing a portfolio of first-in-class therapies to halt fibrosis progression, reported that the first cohort of participants in a phase 1 trial evaluating the safety and tolerability of MTX-463 has been dosed after the FDA approved its investigational new drug (IND) application. MTX-463 is a first-in-class human IgG1 antibody that inhibits WISP-1-mediated fibrotic signaling in order to treat IPF and other fibrotic illnesses. 

The phase 1 research for MTX-463 aims to evaluate its safety at various dose levels, tolerability, and pharmacokinetics, as well as its potential to activate its target, WISP-1. The experiment is enrolling healthy subjects and is divided into two cohorts: staggered single ascending dose (SAD) and multiple ascending dosage (MAD).

"Advancing our first-in-class portfolio to the clinic is an important milestone for Mediar, and an exciting moment envisioned by our founders at Mass General Brigham and advanced by our team," said Mediar's chief executive officer Rahul Ballal, Ph.D.  "MTX-463 is the first of two programs to begin clinical trials this year and we look forward to initiating a second phase 1 study with our first-in-class anti-EphrinB2 molecule, MTX-474, in the third quarter."

As Mediar moves MTX-463 and MTX-474 into human trials, it will be directed by its clinical advisory board, which includes world-renowned professionals in fibrosis from pulmonology, rheumatologist, hepatology, and regulatory. "With the formation of our CAB, we bring together a wealth of experience and expertise to help advance the clinical development of our pipeline as we work to address the significant unmet need in fibrosis," said Mediar's chief medical officer Jeff Bornstein, M.D.