Evotec SE has announced that partner Bayer AG has initiated a phase 2 clinical study of BAY 3401016, a monoclonal antibody targeting Semaphorin-3A (Sema3A), as a potential treatment for Alport syndrome.
The programme stems from a multi-target research collaboration between the two companies in kidney diseases. Evotec is set to receive a milestone payment upon first patient dosing, expected in early 2026.
Bayer’s ASSESS study is a randomised, double-blind, placebo-controlled, parallel group phase 2a trial with an extension phase. It will evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome.
The collaboration between Evotec and Bayer began in August 2016 and includes provisions for further development and sales milestones as well as tiered royalties on net sales if the drug progresses to commercialisation.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: “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.
He added: “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.”
Sema3A is an extracellular guidance protein and regulator of the actin cytoskeleton. Its upregulation in injured kidneys has been linked to the progression of acute and chronic kidney diseases. The antibody developed by Bayer and Evotec blocks Sema3A activity and is being investigated to delay disease progression and the onset of end-stage renal disease in Alport syndrome patients.
Alport syndrome is a genetic condition characterised by kidney disease, hearing loss and eye abnormalities. Most patients experience progressive kidney function loss, often leading to end-stage disease, with hearing loss typically developing in late childhood or adolescence.
The condition is usually inherited in an X-linked manner but can also be passed on through autosomal recessive or, rarely, autosomal dominant inheritance.
