Stanford University Secures NIH Grant to Advance tiakis Biotech´s Elafin (Tiprelestat) Through a U.S. Phase II Trial in Pulmonary Arterial Hypertension

- Novel, disease-modifying treatment option for Pulmonary Arterial Hypertension (PAH), an orphan indication with a significant unmet medical need

Kiel, GERMANY, September 8, 2025 – tiakis Biotech AG (“tiakis”), a clinical-stage biopharmaceutical company developing novel therapeutics for life-threatening pulmonary and cardiovascular diseases, today announced that its long-standing collaboration partner Stanford University has been awarded a US$ double-digit million grant from the National Institutes of Health (NIH) - National Heart Lung and Blood Institute (NHLBI) - the Lung Division, to fund a U.S. Phase II trial of Tiprelestat for the treatment of Pulmonary Arterial Hypertension (PAH). In early 2025, the U.S. FDA has issued positive scientific advice on the planned trial design. The first patients are expected to be treated by Stanford University in mid-2026.

Tiprelestat has been developed by tiakis as an investigational disease-modifying therapy for PAH that has the ability to address the underlying inflammation and potentially reverse the vascular remodeling caused by this debilitating and fatal rare disease. Tiprelestat has already demonstrated an excellent safety profile in five clinical trials involving over 100 subjects. Tiprelestat has received orphan designation for PAH in the U.S. and in Europe. tiakis will provide Stanford with the clinical trial materials for this U.S. study at its own expense.

Existing PAH treatments aim to restore the balance of vasoconstriction and vasodilation, targeting pathways such as endothelin, nitric oxide, and prostacyclin. Nevertheless, the 5-year survival rate in PAH is only 57%, according to registry data. Therefore, there is an urgent medical need for new therapies specifically targeting pulmonary vascular remodeling and inflammation.

“The NIH grant is an outstanding validation and recognition of Tiprelestat’s robust science and its potential to deliver a truly transformative therapy for PAH patients. The investigative team thanks tiakis, our long-standing collaboration partner, for its commitment to supporting Stanford University in this U.S. Phase II trial,” said Professor Roham Zamanian, MD, Director of the Adult Pulmonary Hypertension Program at Stanford University and Principal Investigator of the trial.

“Tiprelestat holds the promise of a disease-modifying therapy because of its unique mechanism of action which addresses major pathological processes in PAH, specifically inflammation and BMPR2 deficiency,“ added Professor Marlene Rabinovitch, MD, the Dwight and Vera Dunlevie Professor of Pediatric Cardiology, and Director of the Basic Science and Engineering Initiative of the Children's Heart Center at Stanford University and Principal Investigator of the trial. “Data from the planned U.S. Phase II trial are expected to confirm this hypothesis.”

“We would like to congratulate Drs. Roham Zamanian and Marlene Rabinovitch on receiving this prestigious NIH award. We also congratulate the leader of the companion award to the Data Coordinating Center for this trial, Dr. Cathie Spino at the SABER unit of the University of Michigan. This award recognizes Tiprelestat’s potential and pioneering approach by scientific and clinical experts at this well-respected institute,” said Martin Voss, CEO of tiakis Biotech AG.

Research reported in this publication will be supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number UG3HL180990. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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About tiakis Biotech

tiakis Biotech AG is an innovative, clinical-stage pharmaceutical company specializing in groundbreaking approaches to protect human tissues and organ structures. The Company develops anti-inflammatory treatments with a primary focus on pulmonary arterial hypertension (PAH). tiakis´ lead candidate Tiprelestat is in clinical development and addresses unmet medical needs in life-threatening conditions. The Company is based in Kiel, Germany.

For further information, please visit https://tiakis.bio.

Contact

tiakis BIOTECH AG
Sophienblatt 40
24103 Kiel
Germany
phone: +49 431 8888-462
fax: +49 431 8888-463
email: info@tiakis.bio

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

Stanford University
Roham T. Zamanian, MD, FCCP
Professor of Medicine
Director, Adult Pulmonary Hypertension Program
Associate Director, Vera Moulton Wall Center for Pulmonary Vascular Disease
Division of Pulmonary & Critical Care Medicine
Stanford University School of Medicine
email: zamanian@stanford.edu

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