tiakis Biotech AG Receives Positive Scientific Advice from the U.S. FDA for Planned Phase II Trial of Tiprelestat

- tiakis and Stanford University are preparing for a Phase II in Pulmonary Arterial Hypertension (PAH)

/EIN News/ -- Kiel, Germany, January 8, 2025 – tiakis Biotech AG, a clinical-stage biopharmaceutical company developing novel therapeutics for life-threatening pulmonary and cardiovascular diseases, today announced that the Company has received positive scientific advice from the U.S. FDA on a planned Phase II trial for the treatment of Pulmonary Arterial Hypertension (PAH). The FDA supports the study design of the so-called ATHENA trial and its primary and secondary endpoints. Tiprelestat has already been granted orphan designation in PAH in the U.S. and in Europe.

The ATHENA trial will be a randomized, double-blind study with three cohorts enrolling 90 patients. The goal of the trial is to assess the safety and efficacy of Tiprelestat versus placebo in combination with standard of care in PAH patients. Primary endpoint will be Pulmonary Vascular Resistance (PVR) and secondary endpoint 6 Minute Walk Distance (6MWD). The design includes a 4-week withdrawal period to study the disease modification potential of Tiprelestat. tiakis is now preparing for the start of the ATHENA trial by conducting a six-month repeat-dose toxicology study in rats.

Tiprelestat (human recombinant Elafin) is an anti-inflammatory human protein and a reversible inhibitor of human neutrophil elastase and proteinase 3 as well as an inhibitor of the formation of neutrophil exosomes and neutrophil extracellular traps. In animal models, Tiprelestat has shown vascular remodeling capabilities. A significant mechanistic imbalance between neutrophil elastase levels and relative Elafin deficiency was identified in PAH patient cohorts.

“It is exciting to evaluate the therapeutic potential of Tiprelestat in PAH in a Phase 2 clinical trial,” said Dr. Roham Zamanian, Professor of Medicine at Stanford University and Principal Investigator of the ATHENA trial. “Given its unique mechanism of action addressing major pathological processes in PAH, specifically inflammation and BMPR2 deficiency, Tiprelestat holds the promise of a disease-modifying therapy for PAH. Data from the planned 4-week withdrawal period are expected to confirm this hypothesis.”

Furthermore, tiakis will attend the upcoming JP Morgan Healthcare conference in San Francisco, CA, and will be available for meetings with investors and biopharmaceutical companies.

###

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 to prevent severe organ damage and failure, particularly after invasive surgeries, 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