Alentis Therapeutics has dosed the first subject in a Phase II clinical study of its investigational monoclonal antibody, lixudebart, to treat organ fibrosis.

Previously known as ALE.F02, lixudebart is a new antibody designed to target fibrosis in the liver, lungs, and kidneys.

It aims to halt and potentially reverse the advancement of the disease by specifically targeting a distinct CLDN1 epitope found in fibrotic tissue.

The placebo-controlled, randomised, double-blind trial is assessing the tolerability, pharmacokinetics, and safety of the drug, as well as its protective ability against the loss of kidney function.

It will also evaluate the renal sparing efficacy of lixudebart and intends to recruit subjects with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis with rapidly progressive glomerulonephritis (RPGN), a rare, severe and potentially fatal disease.

This disease usually leads to a quick and significant decline in kidney function, potentially leading to the need for dialysis or a kidney transplant.

Atlantischief medical officer Dr Luigi Manenti said: “With lixudebart (ALE.F02), we explore a truly novel approach in ANCA-RPGN patients. It is the second clinical trial investigating lixudebart in patients after the initiation of a clinical study in advanced liver fibrosis patients earlier this year.

“The ANCA-RPGN trial is a steppingstone to develop lixudebart for other more common renal indications that are characterised by high CLDN1 expression, such as lupus nephritis​, IgA nephropathy​, and diabetic nephropathy.”

Last month, Alentis dosed the first patient in a Phase I/II clinical trial of its investigational antibody, ALE.C04, for the treatment of patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

The multicentre, open-label, first-in-human trial is designed to assess ALE.C04 as a single agent and in combination with pembrolizumab in 220 adult patients.