tiakis Biotech AG announced results from its Phase Ib/II COMCOVID trial evaluating Tiprelestat for hospitalized COVID-19 patients. The randomized, double-blind, placebo-controlled study, supported by the German Federal Ministry of Education and Research (BMBF), aimed to assess the safety and efficacy of Tiprelestat in this patient population.
Tiprelestat is an anti-inflammatory human protein that acts as a reversible inhibitor of human neutrophil elastase and proteinase 3. It also inhibits the formation of neutrophil exosomes and neutrophil extracellular traps. The drug is being developed for diseases characterized by an overreaction of innate immune responses, such as pulmonary arterial hypertension (PAH) and COVID-19.
Trial Design and Results
Due to a decrease in COVID-19 hospitalizations during the study period, the trial enrolled 17 patients (9 Tiprelestat, 8 placebo). While the small sample size limited the ability to draw definitive efficacy conclusions, exploratory analyses revealed potentially interesting trends. The mean duration of oxygen support (COVID-19 WHO-CPS ≥5) was lower in the Tiprelestat group (2.4 ± 3.6 days) compared to the placebo group (4.0 ± 6.2 days). Additionally, the Tiprelestat group had no days with relevant renal issues after day 1, compared to 1.5 ± 4.2 days in the placebo group.
Consistent with previous trials, Tiprelestat demonstrated a favorable safety profile. Adverse events, clinical laboratory parameters, and vital signs indicated that Tiprelestat was safe and well-tolerated when administered via infusion over 7 days. Pharmacokinetic evaluation showed no accumulation of Tiprelestat in blood plasma.
Expert Commentary
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, stated, "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."
Martin Voss, CEO of tiakis Biotech AG, added, "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."
The summary of the clinical study report is publicly available in the German Registry for Clinical Trials.
