– Presenting a new, disease-modifying therapeutic approach for Pulmonary Arterial Hypertension (PAH), a rare disease with substantial unmet medical requirements
Kiel, GERMANY, September 8, 2025 – tiakis Biotech, a clinical-stage biopharmaceutical firm dedicated to creating innovative treatments for severe pulmonary and cardiovascular conditions, disclosed today that Stanford University, its long-term collaborative partner, has received a grant in the double-digit millions of US dollars from the National Institutes of Health (NIH) – specifically from the National Heart, Lung, and Blood Institute (NHLBI)’s Lung Division. This funding is designated for a U.S. Phase II clinical trial of Tiprelestat, aimed at treating Pulmonary Arterial Hypertension (PAH). Earlier in 2025, the U.S. FDA provided favorable scientific guidance concerning the proposed trial design. Stanford University anticipates enrolling and treating the initial group of patients by mid-2026.
Tiprelestat, developed by tiakis, is an investigational therapy designed to modify the course of PAH. It targets the fundamental inflammation and holds the potential to counteract the vascular remodeling associated with this severe and often fatal rare condition. With five prior clinical trials involving more than 100 participants, Tiprelestat has shown a commendable safety profile. It has also been granted orphan drug designation for PAH in both the U.S. and Europe. tiakis will supply Stanford with all necessary clinical trial materials for this U.S. study, covering the costs itself.
Current treatments for PAH primarily focus on re-establishing the equilibrium between vasoconstriction and vasodilation by influencing pathways like endothelin, nitric oxide, and prostacyclin. However, registry data indicates that the 5-year survival rate for PAH patients remains a mere 57%. This highlights a critical and pressing requirement for novel therapies that directly address pulmonary vascular remodeling and inflammation.
“This NIH grant represents exceptional validation and acknowledgment of Tiprelestat’s solid scientific foundation and its capacity to provide a genuinely transformative treatment for individuals with PAH,” stated Professor Roham Zamanian, MD, who serves as the Director of the Adult Pulmonary Hypertension Program at Stanford University and as a Principal Investigator for the trial. He added, “The research team extends its gratitude to tiakis, our enduring collaborative partner, for their dedication to assisting Stanford University with this U.S. Phase II trial.”
“Tiprelestat shows considerable promise as a disease-modifying treatment due to its distinctive mechanism of action, which targets key pathological processes in PAH, particularly inflammation and BMPR2 deficiency,” commented Professor Marlene Rabinovitch, MD, the Dwight and Vera Dunlevie Professor of Pediatric Cardiology and Director of the Basic Science and Engineering Initiative at the Children’s Heart Center at Stanford University, also a Principal Investigator for the trial. She further noted, “We anticipate that data from the forthcoming U.S. Phase II trial will substantiate this hypothesis.”
“We extend our congratulations to Drs. Roham Zamanian and Marlene Rabinovitch for securing this esteemed NIH award,” said Martin Voss, CEO of tiakis Biotech AG. He added, “Our congratulations also go to Dr. Cathie Spino at the SABER unit of the University of Michigan, who leads the complementary award for the Data Coordinating Center for this trial. This recognition from scientific and clinical authorities at such a highly regarded institution underscores Tiprelestat’s potential and its innovative methodology.”
The research mentioned in this publication will receive funding from the National Heart, Lung, and Blood Institute of the National Institutes of Health, under Award Number UG3HL180990. The information presented herein reflects solely the views of the authors and does not invariably reflect the official stances of the National Institutes of Health.
###
About tiakis Biotech
tiakis Biotech AG operates as an inventive, clinical-stage pharmaceutical enterprise, concentrating on pioneering strategies for safeguarding human tissues and organ systems. The Company is engaged in developing anti-inflammatory therapies, with a principal emphasis on pulmonary arterial hypertension (PAH). tiakis’ flagship candidate, Tiprelestat, is currently undergoing clinical development and aims to fulfill critical unmet medical requirements in severe, life-threatening ailments. The Company’s headquarters are located in Kiel, Germany.
For additional details, kindly visit
Contact
tiakis BIOTECH AG
Sophienblatt 40
24103 Kiel
Germany
phone: +49 431 8888-462
fax: +49 431 8888-463
email:
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:
