Mediar Therapeutics has dosed the first patient as part of a Phase I clinical trial evaluating MTX-474, a first-in-class human IgG1 antibody aimed at halting fibrosis progression.
MTX-474 aims to neutralise the EphrinB2 signalling that causes fibrosis onset and progression.
The clinical trial, taking place in Australia, will evaluate the tolerability, safety, pharmacokinetics, and target engagement of MTX-474 in healthy volunteers.
It will be assessed through single ascending and multiple ascending dose cohorts.
The company is concurrently advancing its US Phase I trial of MTX-463, another first-in-class antibody targeting WNT1-inducible signalling pathway protein-1 (WISP1), with the majority of cohorts already dosed.
This trial is expected to conclude by the end of this year.
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By GlobalDataMTX-463 has shown promising results in vitro and in preclinical mouse models, reducing fibrosis across several indications.
The Phase I study for MTX-463 aims to assess its safety at multiple dose levels, tolerability, and pharmacokinetics of the antibody. It will also evaluate the antibody’s ability to engage its target, WISP-1.
The antibody received orphan drug and fast-track designations from the Food and Drug Administration (FDA).
Mediar Therapeutics CEO Rahul Ballal said: “Dosing participants in our MTX-474 trial marks another important milestone for Mediar and, alongside our ongoing Ph-1 MTX-463 study, opens new potential pathways to target fibrosing diseases.
“Furthermore, the FDA granting both orphan drug and fast track designations for MTX-463 emphasises the potential of this novel therapy to address the high unmet need in IPF.”