Tiakis Biotech Reports Phase Ib/II Trial Results for Tiprelestat in Hospitalized COVID-19 Patients

On December 9, 2024, tiakis Biotech AG, a biopharmaceutical company focused on developing treatments for severe pulmonary and cardiovascular diseases, shared the outcomes of its Phase Ib/II COMCOVID trial, which evaluated Tiprelestat in patients hospitalized with COVID-19. This clinical trial was funded by the German Federal Ministry of Education and Research (BMBF) in 2021.

Tiprelestat, a human recombinant protein Elafin, is known for its anti-inflammatory properties. It acts as a reversible inhibitor of human neutrophil elastase and proteinase 3 and prevents the formation of neutrophil exosomes and extracellular traps. This compound is being explored for its therapeutic potential in diseases marked by an excessive innate immune response, such as pulmonary arterial hypertension (PAH) and COVID-19.

Throughout the trial, tiakis Biotech had to adapt to the evolving COVID-19 pandemic, which caused a notable decrease in hospitalizations. Consequently, the study managed to recruit and treat only 17 patients, with 9 receiving Tiprelestat and 8 on a placebo.

Although the small sample size limits the ability to draw definitive conclusions about efficacy, the trial still reported all observed outcomes. Notably, the average number of days requiring any oxygen support was lower in the Tiprelestat group (2.4 ± 3.6 days) compared to the placebo group (4.0 ± 6.2 days). Additionally, patients in the Tiprelestat group experienced no renal issues post-day 1, while the placebo group had an average of 1.5 ± 4.2 days with renal complications.

In alignment with previous studies, the trial indicated that Tiprelestat is safe and well tolerated when administered via infusion over a 7-day regimen. The pharmacokinetic data also suggested that Tiprelestat does not accumulate in blood plasma.

Dr. Michael Dreher, the lead medical investigator of the trial and a Professor of Medicine and Pneumology at the University Hospital Aachen, Germany, commented on the findings. He stated that despite not achieving the targeted patient number, the data underscores the safety profile of Tiprelestat, showing it can be administered repeatedly without significant adverse effects in a diverse patient population aged up to 89 years with severe inflammatory lung disease.

Martin Voss, CEO of tiakis Biotech AG, expressed his gratitude to the colleagues and partners who worked under challenging pandemic conditions. He emphasized that the solid safety data will bolster the development of Tiprelestat for other pulmonary diseases.

The summary of this clinical study report is available in the German Registry for Clinical Trials.

tiakis Biotech AG, headquartered in Kiel, Germany, is an innovative pharmaceutical company at the clinical stage. It focuses on developing anti-inflammatory treatments designed to prevent severe organ damage and failure, especially following invasive surgeries. The company's lead candidate, Tiprelestat, is in clinical development to address unmet medical needs in life-threatening conditions such as PAH.