Clinical Progress Continues as Evotec and Bayer Move Kidney Disease mAb Candidate Into Phase 2 Testing

Clinical Progress Continues as Evotec and Bayer Move Kidney Disease mAb Candidate Into Phase 2 Testing

(IN BRIEF) Evotec SE announced that Bayer has initiated a Phase 2 clinical study for BAY 3401016, a Semaphorin-3A-targeting monoclonal antibody being developed as a potential therapeutic option for patients with Alport syndrome. As part of the companies’ kidney disease collaboration established in 2016, Evotec anticipates a milestone payment once the first patient receives the investigational therapy, planned for early 2026. The Phase 2a ASSESS trial is designed as a double-blind, randomized, placebo-controlled study to evaluate safety and efficacy in adults aged 18–45. With Alport syndrome being a rare genetic kidney disorder that can lead to end-stage renal disease alongside hearing and vision complications, the development of BAY 3401016 represents a meaningful step forward in addressing an unmet clinical need. Evotec’s CSO Dr Cord Dohrmann expressed optimism over the study launch, emphasizing the urgent need for new therapies to improve patient outcomes and delay disease progression.

(PRESS RELEASE) HAMBURG, 5-Dec-2025 — /EuropaWire/ — Evotec SE has announced progress in its long-standing kidney disease partnership with Bayer AG, as Bayer has now begun a Phase 2 clinical trial to evaluate BAY 3401016 — a monoclonal antibody (SEMA3A mAb) designed to target Semaphorin-3A — as a potential therapy for patients living with Alport syndrome. This advancement triggers the next stage of development within the joint research program first formed in 2016, and Evotec expects to receive a milestone payment upon dosing of the first study participant, currently projected for early 2026. The investigational drug aims to address a rare inherited kidney condition that significantly affects quality of life and often progresses to end-stage renal disease.

The newly launched Phase 2a ASSESS study will be conducted as a randomized, double-blind, placebo-controlled trial with parallel-group design and an extension phase. It will evaluate the safety and clinical efficacy of BAY 3401016 in adult patients aged 18 to 45 diagnosed with Alport syndrome. As part of the collaboration framework, the programme allows for additional development and commercial milestones, alongside tiered royalties linked to future net sales, depending on clinical and commercial outcomes.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, highlighted the importance of this milestone, noting that Alport syndrome is a progressive disease that begins early in life and can lead to a lifelong medical burden for patients and families. He noted that improved therapeutic solutions are urgently needed and expressed pride in seeing the antibody candidate move into the next phase of development. Dohrmann congratulated Bayer for initiating Phase 2 clinical testing and reaffirmed Evotec’s commitment to supporting the programme as it moves forward.

About Semaphorin-3A

Semaphorin-3A is an extracellular guidance molecule known to regulate actin cytoskeleton dynamics. Disruption in podocyte cytoskeleton structure plays a critical role in the pathology of Alport syndrome. Upregulation of Sema3A has been observed in injured kidneys, linking it to the progression of both acute and chronic kidney disease. The antibody developed under the Evotec-Bayer collaboration is designed to inhibit Sema3A activity, with the therapeutic aim of slowing disease advancement and delaying progression toward end-stage renal failure.

About Alport Syndrome

Alport syndrome is an inherited disorder affecting kidney filtration, hearing and ocular health. The condition most commonly follows an X-linked pattern associated with mutations in the COL4A5 gene, while autosomal recessive or rare autosomal dominant forms relate to COL4A3 and COL4A4 gene variants. Progressive loss of kidney function is a defining feature, often accompanied by hearing impairment arising in later childhood or early teenage years. While eye abnormalities are typical, they seldom result in severe vision loss. Diagnosis may involve clinical assessment, kidney biopsies, and is confirmed through genetic testing.

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Media
Susanne Kreuter
VP Head of Strategic Marketing
Susanne.Kreuter@evotec.com

Investor Relations
Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

SOURCE: Evotec