–       Tiprelestat demonstrated a favorable safety profile and preliminary signs of effectiveness.

Kiel, Germany, December 9, 2024 – tiakis Biotech AG, a clinical-stage biopharmaceutical company focused on developing novel treatments for life-threatening pulmonary and cardiovascular diseases, today announced results from its randomized, double-blind, placebo-controlled Phase Ib/II COMCOVID clinical trial. This trial assessed Tiprelestat’s efficacy in treating hospitalized COVID-19 patients. In 2021, tiakis Biotech received funding from the German Federal Ministry of Education and Research (“BMBF”) to launch the COMCOVID trial.

Tiprelestat (human recombinant Elafin) is an anti-inflammatory human protein. It acts as a reversible inhibitor of human neutrophil elastase and proteinase 3, and also inhibits the formation of neutrophil exosomes and neutrophil extracellular traps. The compound is being developed as a potential treatment for diseases marked by an excessive innate immune response, such as pulmonary arterial hypertension (PAH) and COVID-19.

Due to evolving pandemic circumstances, the trial’s recruitment faced challenges, resulting in a smaller-than-planned participant pool. A total of 17 patients (9 receiving Tiprelestat, 8 receiving placebo) completed the trial.

While the small sample size limits definitive efficacy conclusions, all efficacy data are being reported. Exploratory analyses showed fewer days requiring any oxygen support (COVID-19 WHO-CPS ≥5 score points) in the Tiprelestat group (2.4 ± 3.6 days) compared to the placebo group (4.0 ± 6.2 days). Additionally, the Tiprelestat group experienced zero days with significant renal issues after day 1, compared to 1.5 ± 4.2 days in the placebo group.

Consistent with prior trials, Tiprelestat demonstrated a safe and well-tolerated profile when administered via infusion over seven days. Pharmacokinetic evaluation showed no Tiprelestat accumulation in blood plasma.

“Although the trial did not meet its recruitment target and definitive efficacy conclusions are not possible, the data strengthen our confidence in Tiprelestat’s safety profile, showing it can be repeatedly administered without substantial adverse effects in this patient population (aged up to 89 years) experiencing severe inflammatory lung disease,” stated Dr. Michael Dreher, Professor of Medicine/Pneumology and Head of the Department of Pneumology and Intensive Care Medicine at University Hospital Aachen, Germany, and lead medical investigator of the COMCOVID trial.

“The robust safety data and supportive findings in this diverse and vulnerable patient group will bolster Tiprelestat’s development for other pulmonary diseases. I thank our colleagues and partners for their exceptional work under challenging pandemic circumstances,” added Martin Voss, CEO of tiakis Biotech AG.

The clinical study report summary is publicly accessible in the German Registry for Clinical Trials ().

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About tiakis Biotech

tiakis Biotech AG is an innovative, clinical-stage pharmaceutical company specializing in novel approaches to protect human tissues and organs. The Company develops anti-inflammatory treatments to prevent severe organ damage and failure, especially after invasive surgeries, with a primary focus on pulmonary arterial hypertension (PAH). tiakis´ lead candidate, Tiprelestat, is undergoing clinical development to address 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
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