Alentis Therapeutics launches first-in-human clinical studies

Founded in 2019, Alentis is a clinical stage biopharma focused on discovering and developing novel therapies for the treatment of unmet fibrotic diseases. In the US and Europe alone, about 45% of deaths can be attributed to fibrotic disorders. Fibrosis affects nearly all tissues and organ systems such as the liver, kidneys, and lungs. Advanced liver fibrosis and associated cirrhosis is the fastest-growing indication for liver transplantation in the United States. While multiple investigational agents target mechanisms that impact the earlier metabolic stages of the fibrosis development, Alentis is targeting clinically advanced liver fibrosis associated with different etiologies through inhibition of Claudin-1, a recently discovered therapeutic target for organ fibrosis.

Unlike current therapies in fibrosis, which mostly address the disease indirectly, Alentis’ pioneering approach has the potential to directly modify and reverse the course of disease progression

The company’s drug candidate ALE.F02, is a highly selective anti-Claudin-1 mAb that recognizes pathological overexpressed and conformation-dependent Claudin-1 epitopes in fibrotic disease. In preclinical studies, the lead molecule ALE.F02 modulates the function of non-junctional Claudin-1, preventing, and possibly reversing, the growth of fibrotic tissue within the liver and kidney by changing the plasticity of key cell types mediating fibrosis. Safety studies in non-human primates have supported translatability of the approach into patients.

Today, the company announced the dosing of the first patient, kicking off its phase-1 clinical trials. "ALE.F02 has demonstrated compelling safety and efficacy in preclinical patient-derived models of liver and kidney fibrosis. We look forward to further investigating this compound, in this dose-escalating Phase 1 study," said Markus Meyer, Vice President R&D. Roberto Iacone, CEO of Alentis Therapeutics added, "We believe our differentiated approach of inhibiting pathological overexpressed and conformation-dependent Claudin-1 epitopes in liver and kidney fibrosis holds the potential to reverse clinically advanced fibrosis.”

Alentis is headquartered in Basel’s pharma-biotech hub in Switzerland with a subsidiary for R&D in Strasbourg, France.

(Press release/RAN)