The results from both trials are in line with the safety outcomes of a Phase I trial involving healthy volunteers. Credit: Andrei_R / Shutterstock.

Swiss pharmaceutical company Alentis Therapeutics has reported positive topline outcomes from two clinical trials of its monoclonal antibody, lixudebart (ALE.F02), for reversing organ fibrosis.

The trials demonstrated dose-dependent target engagement and preliminary evidence of ‘improved’ organ function.

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The ongoing Phase II RENAL-F02 trial has enrolled 26 subjects dosed for up to 24 weeks while the Phase Ib FEGATO-01 study has involved 41 subjects with advanced F3/F4 liver fibrosis and/or mild cirrhosis being dosed for up to four weeks.

In both studies, the therapy showed a ‘favourable’ safety profile as a single agent and in conjunction with standard of care, across 51 active subjects.

These results are in line with the safety outcomes of a Phase I trial involving healthy volunteers.

Alentis Therapeutics chief medical officer Luigi Manenti said: “The results from the two studies are very encouraging, particularly given the dose-dependent target engagement and favourable safety profile.

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“We also observed an initial decrease in ALT/AST in liver fibrosis patients treated with lixudebart.”

Developed for the treatment of fibrosis in the liver, lungs and kidneys, lixudebart targets the claudin-1 (CLDN1) epitope found in fibrotic tissue.

Following Phase I trials, the therapy was reported to have been well-tolerated, with no serious safety concerns raised.

It has received orphan drug designation from the Food and Drug Administration (FDA) for treating idiopathic pulmonary fibrosis.

Based in Allschwil, Alentis specialises in antibody-drug conjugates (ADCs) and antibodies targeting CLDN1 for oncology and multi-organ fibrosis treatments.

The company’s lead ADC candidate, ALE.P02, has been awarded fast track status by the FDA for advanced or metastatic CLDN1+ squamous cancer treatment.

Alentis has clinical operations in the US and a research and development subsidiary in Strasbourg, France.

In December 2023, the company dosed the first subject in a Phase II trial of lixudebart for treating organ fibrosis.