German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) announced on Thursday that it has initiated a Phase IIa clinical trial of BAY 3401016, an investigational monoclonal antibody designed to block Semaphorin 3A (Sema3A), a protein implicated in kidney damage in Alport Syndrome (AS).

The ASSESS study is a randomised, double-blind, placebo-controlled trial with an extension phase, evaluating the safety and efficacy of BAY 3401016 in adults with rapidly progressing AS.

Alport Syndrome is a rare genetic disorder caused by mutations affecting type IV collagen, leading to proteinuria, progressive kidney failure, and early onset of end-stage renal disease. Currently, there is no specific treatment approved for AS.

Diagnosis occurs via urine tests, kidney biopsy, or genetic testing, and disease progression varies, often affecting men earlier while women may experience milder or later onset symptoms.

Bayer's BAY 3401016 programme builds on a strategic research collaboration with Evotec and represents a key addition to the company's development portfolio for rare kidney diseases. The programme has received both Fast Track Designation and Orphan Drug Designation from the US Food and Drug Administration (FDA).

The new Phase IIa trial aims to determine the potential of BAY 3401016 to slow kidney function decline in adult AS patients, addressing a high unmet medical need.