- Tiprelestat was safe and well tolerated, with initial signs of clinical efficacy
Kiel, Germany, December 9, 2024 – tiakis Biotech AG, a clinical-stage biopharmaceutical company developing novel therapeutics for life-threatening pulmonary and cardiovascular diseases, today announced the results of its randomized, double-blind, placebo-controlled clinical Phase Ib/II COMCOVID trial evaluating Tiprelestat for the treatment of patients hospitalized due to COVID-19. In 2021, tiakis Biotech received support from the German Federal Ministry of Education and Research (“BMBF”) to initiate the COMCOVID trial.
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. The compound is in development as a potential therapeutic in diseases characterized by an adverse overreaction of innate immune responses, e.g., pulmonary arterial hypertension (PAH) or COVID-19.
During the study period, tiakis had to adapt to changes in the COVID-19 pandemic, which led to a significant decrease in the rate of hospitalizations due to this disease. 17 patients could be recruited and treated (9 Tiprelestat, 8 placebo) until the end of the trial period.
Even though the power of the small sample size of this study does not allow for a reliable efficacy assessment, it was decided to report all efficacy results. From an exploratory perspective, it is interesting to note that the number of days (mean ± SD) with any oxygen support (i.e. COVID-19 WHO-CPS ≥5 score points) was lower in the Tiprelestat group (2.4 ± 3.6 days) compared to placebo (4.0 ± 6.2 days). In addition, the number of days with relevant renal issues after day 1 was zero in the Tiprelestat group (0 ± 0) compared to the placebo group (1.5 ± 4.2).
Consistent with previous clinical trials, the results regarding adverse events, clinical laboratory parameters and vital signs demonstrate that Tiprelestat was safe and well tolerated when administered via infusion in a multiple dose regimen over 7 days. In addition, results of pharmacokinetic evaluation show that Tiprelestat does not accumulate in blood plasma.
“Although the trial did not reach the targeted patient number and we cannot draw a reliable conclusion on efficacy, the data reinforce our confidence in the safety profile of Tiprelestat, indicating that it can be administered repeatedly without significant adverse effects in this patient population aged up to 89 years and suffering from a severe inflammatory lung disease,” said Dr. Michael Dreher, Professor of Medicine / Pneumology and Head of the Department of Pneumology and Intensive Care Medicine at the University Hospital Aachen, Germany, and lead medical investigator of the COMCOVID trial.
“The solid safety and supportive data in such a diverse and vulnerable patient population will strengthen the development of Tiprelestat in other pulmonary diseases. I would like to thank all our colleagues and partners for their fantastic work under such challenging and unprecedented pandemic conditions,” added Martin Voss, CEO of tiakis Biotech AG.
The summary of the clinical study report is publicly available in the German Registry for Clinical Trials (https://drks.de/search/en/trial/DRKS00031463).
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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 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.
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tiakis Biotech AG
Sophienblatt 40
24103 Kiel
Germany
phone: +49 431 8888-462
fax: +49 431 8888-463
email: info@tiakis.bio
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