Evotec and Bayer Advance Novel Antibody into Phase 2 Trial for Alport Syndrome
Evotec SE has announced a key clinical milestone in its long-standing kidney disease partnership with Bayer AG, as Bayer initiates a phase 2 clinical study of BAY 3401016, a monoclonal antibody targeting Semaphorin-3A (Sema3A), for the treatment of Alport syndrome.
The programme is the result of a multi-target research collaboration between the two companies focused on innovative therapies for kidney conditions. Under the terms of the agreement, Evotec will receive a milestone payment upon first patient dosing in this trial, which is expected to take place in early 2026.
Bayer’s phase 2a study, known as ASSESS, is designed as a randomised, double-blind, placebo-controlled, parallel-group clinical trial with an extension phase, reflecting a rigorous approach to evaluating this new therapeutic candidate.
The trial will investigate the efficacy and safety of BAY 3401016 in adults aged 18 to 45 who are living with Alport syndrome. By focusing on this younger adult population, the study aims to intervene at a stage where slowing disease progression could have a meaningful impact on long-term outcomes.
The collaboration between Evotec and Bayer dates back to August 2016 and is structured to support the full lifecycle of drug development. In addition to the current milestone, the agreement includes provisions for further development and sales-related payments, as well as tiered royalties on future net sales, should BAY 3401016 successfully progress through late-stage trials and ultimately reach commercialisation.
This framework underlines both companies’ commitment to long-term investment in kidney disease research and innovation.
Evotec’s Chief Scientific Officer expressed strong optimism about the progress of BAY 3401016, noting that the advancement into phase 2 clinical development marks an important achievement for a programme jointly created to tackle a particularly challenging disease.
They emphasised that Alport syndrome primarily damages the kidneys, often beginning in childhood and worsening over a patient’s lifetime. Beyond the physical symptoms, they highlighted the considerable burden of disease management, especially in the later stages of kidney failure, and stressed the urgent need for new therapeutic options that can improve quality of life for patients and their families.
The CSO also congratulated Bayer on the launch of the phase 2 study and underlined Evotec’s pride in supporting the ongoing advancement of this programme.
At the heart of BAY 3401016’s mechanism of action is Sema3A, an extracellular guidance protein and regulator of the actin cytoskeleton. In the context of kidney health, Sema3A has gained attention because its upregulation in injured kidneys has been associated with the progression of both acute and chronic kidney diseases.
The antibody co-developed by Bayer and Evotec is designed to block Sema3A activity, with the goal of slowing disease progression and delaying the onset of end-stage renal disease in people with Alport syndrome. If successful, this approach could represent a new class of targeted therapy for hereditary kidney disease.
Alport syndrome itself is a genetic condition characterised primarily by kidney disease, but it also frequently involves hearing loss and eye abnormalities. Most affected individuals experience progressive decline in kidney function, with many eventually developing end-stage kidney disease that requires dialysis or a transplant.
Hearing loss often emerges in late childhood or adolescence, adding to the burden on patients and families. The condition is most commonly inherited in an X-linked pattern, but autosomal recessive and, more rarely, autosomal dominant forms are also recognised, complicating diagnosis and family counselling.
In Conclusion
As the ASSESS study gets underway, the initiation of this phase 2 trial represents an important and hopeful step for the Alport community and for kidney disease research more broadly.
BAY 3401016 brings together cutting-edge insights into Sema3A biology with a decade-long research partnership between Evotec and Bayer. While much work remains before the antibody’s full potential can be confirmed, the new study signals real momentum towards improved treatment options.
For patients, families, clinicians and researchers, this development offers a measure of optimism that targeted therapies may, in the future, help slow the march towards end-stage renal disease and improve day-to-day quality of life for those living with Alport syndrome.
News Credits: Bayer begins phase 2 trial of new Alport syndrome therapy
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