Wedoany.com Report-Dec.5, Evotec SE announced that its partner Bayer AG has started a Phase 2 clinical trial of BAY 3401016, a monoclonal antibody targeting Semaphorin-3A (Sema3A), for the treatment of Alport syndrome. The candidate originated from a kidney disease research alliance between the two companies launched in 2016.

The trial, named ASSESS, is a randomised, double-blind, placebo-controlled Phase 2a study with an open-label extension phase. It will assess the efficacy, safety and tolerability of BAY 3401016 in adults aged 18–45 diagnosed with Alport syndrome. The first patient is expected to be dosed in early 2026, triggering a milestone payment to Evotec. Further development, regulatory and commercial milestone payments, plus tiered royalties on future net sales, are included in the collaboration agreement.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, stated: "We are very pleased that our jointly developed antibody, BAY 3401016, for the treatment of Alport syndrome has advanced into phase 2 of clinical development. Alport syndrome primarily damages the kidney, often starting at childhood and worsening through life.

"This debilitating disease significantly impacts patient's quality of life through both the symptoms and disease management, especially in later stages of kidney disease. New therapeutic options that enable better quality of life are urgently needed for individuals and families affected by this disease. The initiation of this study represents an important and hopeful step forward. We congratulate Bayer on the phase 2 launch and are proud to support the advancement of this program."

Semaphorin-3A (Sema3A) is an extracellular protein that regulates the actin cytoskeleton. Increased Sema3A levels in damaged kidneys are associated with progression of both acute and chronic kidney conditions. BAY 3401016 is designed to block Sema3A signalling, with the goal of slowing kidney function decline and delaying the need for dialysis or transplantation in patients with Alport syndrome.

Alport syndrome is a rare hereditary disorder that causes progressive kidney damage, often accompanied by hearing loss and eye abnormalities. Most patients develop gradual loss of kidney function that can lead to end-stage renal disease. Hearing impairment typically appears in late childhood or early adolescence.

The condition is most commonly inherited in an X-linked pattern, although autosomal recessive and, less frequently, autosomal dominant forms also occur.

With the start of the Phase 2 ASSESS trial, BAY 3401016 becomes one of the few targeted therapies in clinical development specifically for Alport syndrome, addressing a significant unmet medical need in this patient population.