Evotec-Partner Bayer Starts Phase 2 Study for Treatment of Patients with Alport Syndrome
Rhea-AI Summary
Evotec (NASDAQ:EVO) confirmed that partner Bayer has initiated a Phase 2 clinical study of BAY 3401016, a monoclonal antibody targeting Semaphorin-3A (Sema3A) for the treatment of Alport syndrome.
The randomized, double-blind, placebo-controlled Phase 2a ASSESS study with an extension phase will enroll participants aged 18 to 45. Under the 2016 collaboration, Evotec is eligible for a milestone payment upon first patient dosing, which Bayer expects in early 2026, and for further development and sales milestones plus tiered royalties if the program advances to commercialization.
Positive
- Phase 2 start for BAY 3401016 in Alport syndrome
- Evotec eligible for milestone upon first patient dosing expected early 2026
- Program originates from a 2016 Evotec–Bayer collaboration
- Evotec eligible for future milestones and tiered royalties
Negative
- Study enrolment restricted to ages 18–45
- Financial upside is contingent on Bayer progress through development and commercialization
Insights
Phase 2 start and an early‑2026 first‑dose milestone make this a clearly positive development for Evotec's partnered kidney program.
Bayer has advanced the jointly developed monoclonal antibody BAY 3401016 (targets Sema3A) into a randomized, double‑blind Phase 2a study for Alport syndrome, creating a clear value inflection tied to clinical progress and associated contractual payments to Evotec. The collaboration structure yields near‑term cash if the first patient is dosed and preserved longer‑term upside via further development milestones and tiered royalties on net sales.
Key dependencies and risks include successful patient dosing and meaningful safety/efficacy readouts in the Phase 2a cohort; outcomes will determine whether subsequent milestones and royalty prospects materialize. Watch for the reported first dosing in
Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome
Milestone payment to Evotec expected upon first dosing of first study participant in early 2026
HAMBURG, DE / ACCESS Newswire / December 4, 2025 / Evotec SE (Frankfurt Stock Exchange:EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ:EVO) today announced that its partner Bayer AG has initiated a Phase 2 clinical study of a kidney disease program originating from the multi-target research collaboration between Evotec and Bayer in kidney diseases. Under the terms of the collaboration agreement, Evotec is eligible to receive a milestone payment upon first patient dosing, which is expected in early 2026. The study drug, BAY 3401016, a monoclonal antibody ("mAb") targeting the protein Semaphorin-3A ("Sema3A") is being developed as a potential treatment for Alport syndrome, a rare genetic kidney disease.
Bayer's ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome. The program originates from a strategic collaboration, which Evotec and Bayer entered in August 2016. Under the terms of the agreement, Evotec is eligible to receive further development and sales milestones as well as tiered royalties of net sales contingent upon the future progress during clinical development and potential commercialization of a drug in the future.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "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."
About Semaphorin-3A
Semaphorin-3A ("Sema3A") is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton. Alterations of the actin cytoskeleton, particularly of podocytes, are a key pathophysiological feature of Alport syndrome, a rare genetic kidney disease with progressive loss of filtration capacity, leading to end stage renal disease, progressive hearing loss and variable vision impairment. Sema3A is upregulated in injured human kidneys and implicated in the development and progression of acute and chronic kidney diseases. The monoclonal antibody ("mAb") developed by Bayer in partnership with Evotec blocks Sema3A activity and is currently investigated as a potential treatment of Alport syndrome, aiming to delay disease progression and onset of end-stage renal disease.
About Alport Syndrome
Alport syndrome is a genetic condition characterized by kidney disease, hearing loss, and eye abnormalities. Most affected individuals experience progressive loss of kidney function, which may lead to end-stage kidney disease. People with Alport syndrome also frequently develop sensorineural hearing loss in late childhood or early adolescence. The eye abnormalities characteristic of this condition seldom lead to vision loss. In
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 SE
View the original press release on ACCESS Newswire
FAQ
What did Evotec announce about BAY 3401016 and Alport syndrome (EVO) on December 4, 2025?
When is Evotec expected to receive the Phase 2 milestone payment for BAY 3401016 (EVO)?
What is the design of Bayer’s ASSESS Phase 2 study for BAY 3401016 (EVO)?
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Does the Phase 2 study cover pediatric Alport syndrome patients for BAY 3401016 (EVO)?
