ANCA-associated vasculitis with kidney damage trial tests lixudebart
26 patients have been followed in assessment of treatment's safety profile
Lixudebart (ALE.F02), an experimental therapy Alentis Therapeutics is developing to help preserve kidney health in ANCA-associated vasculitis, showed a favorable safety profile in a Phase 2 clinical trial, the company has announced.
A separate study testing lixudebart in people with liver disease also showed a good safety profile, and both studies suggest lixudebart is working as intended.
“The results from the two studies are very encouraging, particularly given the dose-dependent target engagement and favorable safety profile,” Luigi Manenti, Alentis’ chief medical officer, said in a company press release.
ANCA-associated vasculitis is a group of autoimmune diseases marked by inflammation in small blood vessels, which often leads to damage in the kidneys. When the kidneys become damaged, they can develop fibrosis, that is, scar tissue, which interferes with normal kidney function. Fibrosis in the kidneys and other organs also plays a role in a wide range of diseases.
Lixudebart is an antibody-based medication designed to alleviate fibrosis by targeting Claudin-1, or CLDN1, a protein involved in the connections between cells that plays roles in developing fibrosis.
A favorable safety profile for lixudebart
The Phase 2 study RENAL-F02 (NCT06047171) tested lixudebart in people with ANCA-associated vasculitis who had rapidly progressive glomerulonephritis (ANCA-RPGN), which refers to aggressive kidney inflammation that can set the stage for fibrosis. The study’s participants received infusions of lixudebart at one of three doses, or a placebo, on top of standard-of-care therapies. Twenty-six patients have been followed for at least six months in the study, the main goal of which was to assess the treatment’s safety profile.
According to Alentis, the therapy showed a favorable safety profile. A separate study testing lixudebart in people with liver fibrosis also showed good safety outcomes, the company said.
Alentis didn’t provide specifics on safety or efficacy outcomes from the study, but did note that early data suggest lixudebart led to improvements in measures of kidney function such as glomerular filtration rate (GFR) and levels of protein in the urine, or proteinuria, in the ANCA-RPGN study.
“Interim results from the RENAL-F02 study in ANCA-RPGN indicate beneficial effects of lixudebart on [GFR] recovery and proteinuria reduction,” said David Jayne, MD, a professor at Cambridge University. “These observations were further supported by reductions of CD163, a validated urinary biomarker, also indicating an impact on immune cell homing and trafficking to the kidney.”
About the Author
