Mediar Therapeutics has dosed the first subject in the Phase II WISPer trial of its investigational therapy, MTX-463, for idiopathic pulmonary fibrosis (IPF).
The trial is designed to evaluate this human immunoglobulin G1 (IgG1) antibody, which targets WNT1-inducible signalling pathway protein-1 (WISP1), a matricellular protein implicated in the progression of fibrosis.
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Its primary endpoint includes change from baseline in forced vital capacity (FVC) at 24 weeks, a critical measure of lung function.
WISP1 levels in human blood have been shown to correlate with the severity of the disease, and MTX-463 has demonstrated the ability to neutralise WISP1-mediated fibrotic signalling and minimise fibrosis in vitro and in several preclinical models.
This latest announcement follows Mediar’s recent worldwide licensing agreement with Lilly, supporting the progression of the antibody through the Phase II trial.
IPF is stated to be a debilitating lung condition marked by the thickening and scarring of lung tissue, resulting in a persistent dry cough and progressive shortness of breath.
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By GlobalDataMediar Therapeutics chief medical officer Jeff Bornstein said: “Today marks an important milestone in our ongoing commitment to pioneering novel therapies to impact people living with fibrotic diseases. We extend our gratitude to Dr Ryan Klein and the dedicated team at NewportNativeMD whose expertise and collaboration have been instrumental in reaching this important step.
“The first patient dosed with this first-in-class anti-fibrotic marks the beginning of a new chapter in our research, and we look forward to working with our clinical sites as we continue to enrol the Phase II programme.”
In addition to MTX-463, the company is also progressing with its other wholly owned programmes aimed at treating various fibrotic disorders.
MTX-474 is another human IgG1 antibody, tailored to neutralise EphrinB2 signalling, that recently completed its Phase I study.
A Phase II trial of MTX-474 for systemic sclerosis is anticipated to begin in the second half of this year.
The company also noted that its third fibrosis programme, which targets secreted modular calcium-binding protein 2 (SMOC2) for renal fibrosis, is progressing, and a clinical candidate is expected to be nominated in the first half of this year.
