A Phase II, Randomized, Double-Blind, Safety and Efficacy Study of Tiprelestat Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

The primary objective of this study is to compare the efficacy, safety, and tolerability of tiprelestat plus Standard of Care (SOC) compared with placebo plus SOC in patients with World Health Organization (WHO) functional class II-IV pulmonary arterial hypertension (PAH).

Start Date01 Jul 2026

Sponsor / Collaborator

Stanford University

[+2]

NCT03522935

/ CompletedPhase 1IIT

Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects

A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult subjects. The purpose of this study is to assess Elafin that is being developed for treatment of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and is a major factor in the development of PAH. Elafin will be administered subcutaneously daily for 7 days in normal healthy subjects followed over a 28 day time period.

Start Date18 Mar 2019

Sponsor / Collaborator

Stanford University

[+3]

EUCTR2008-000938-49-DE

/ CompletedPhase 2

Placebo-controlled Randomized Trial to evaluate the Effect of Elafin on Cytokine Profiles after Major Surgery - Phase II

Start Date18 Aug 2008

Sponsor / Collaborator-

100 Clinical Results associated with Tiprelestat(Proteo Biotech AG)

100 Translational Medicine associated with Tiprelestat(Proteo Biotech AG)

100 Patents (Medical) associated with Tiprelestat(Proteo Biotech AG)

250

Literatures (Medical) associated with Tiprelestat(Proteo Biotech AG)

01 Mar 2026·ADVANCES IN THERAPY

Correction to: Tiprelestat for Treatment of Hospitalized COVID-19: Results of the Double-Blind Randomized Placebo-Controlled COMCOVID Trial

Author: Tebbe, Johannes-Josef ; Walterspacher, Stephan ; Wege, Henning ; Bollmann, Tom ; Sorichter, Stephan ; Dreher, Michael ; Bergs, Ingmar ; Wiedow, Oliver ; Kelm, Hagen ; Budweiser, Stephan ; Lüth, Stefan ; Henneicke-von Zepelin, Hans-Heinrich

01 Dec 2025·Advanced Science

A Multicenter Validation of a Fully Automated Chemiluminescence Immunoassay for Plasma Elafin in Psoriasis Diagnosis and Severity Assessment

Article

Author: Xiaobo Yu ; Zhining Dong ; Meng Xu ; Jingkun Yi ; Ling Han ; Chuanjian Lu ; Ruimin Liu ; Xiaomei Zhang ; Di Hu

Abstract:

Psoriasis diagnosis and severity assessment rely on subjective skin evaluations. Elafin is a promising biomarker, yet no high‐throughput clinical assay exists. A chemiluminescence immunoassay (CLIA) reagent kit for plasma Elafin has been developed and validated using automated analyzers to enable rapid diagnosis, objective severity stratification, and longitudinal monitoring. Analytical performance is rigorously assessed, including the limit of blank (LoB) (0.069 ng mL −1 ), limit of detection (LoD) (0.099 ng mL −1 ), limit of quantification (LoQ) (0.8 ng mL −1 ), linearity (0.8–200 ng mL −1 ), precision, recovery, reproducibility, and interference resistance. Plasma Elafin is quantified in 731 participants from five hospitals: 112 healthy controls, 466 psoriasis patients (mild = 164, moderate = 158, severe = 144), and 153 disease controls. The assay achieves 89% diagnostic accuracy with an area under the receiver operating characteristic curve (AUC) of 0.94 for psoriasis. It effectively distinguishes disease severity (AUC 0.68 mild vs moderate; 0.77 moderate vs severe), and Elafin levels correlated with treatment duration in moderate (R = 0.51) and severe (R = 0.41) cases. This CLIA reagent kit demonstrates excellent analytical and clinical performance, supporting automated, high‐throughput Elafin detection as a reliable tool for diagnosing and managing moderate‐to‐severe psoriasis.

01 Nov 2025·ADVANCES IN THERAPY

Tiprelestat for treatment of hospitalized COVID-19: results of the double-blind randomized placebo-controlled COMCOVID trial

Article

Author: Tebbe, Johannes-Josef ; Walterspacher, Stephan ; Bollmann, Tom ; Wege, Henning ; Sorichter, Stephan ; Bergs, Ingmar ; Dreher, Michael ; Wiedow, Oliver ; Kelm, Hagen ; Budweiser, Stephan ; Lüth, Stefan ; Henneicke-von Zepelin, Hans-Heinrich

INTRODUCTION:

Tiprelestat (recombinant human elafin) reversibly inhibits human neutrophil elastase. This can reduce overactivity of this enzyme in COVID-19-patients and might prohibit further organ damage and progression to severe disease. This protein had yet not been tested in COVID-19 patients.

METHODS:

This prospective, multicenter, randomized, double-blind, placebo-controlled trial investigated Tiprelestat in adult patients hospitalized for COVID-19 in 7 hospitals in Germany between May 2023 and May 2024. Patients received 100 mg Tiprelestat or placebo twice a day for 7 days, or shorter if no longer hospitalized due to COVID-19. Data about efficacy, safety, and pharmacokinetic trough levels were collected over 29 days.

RESULTS:

A total of 296 patients were planned. Due to slow recruitment during the end of the pandemic, only 17 patients were finally included. Of these, 9 received Tiprelestat and 8 placebo. The mean treatment exposition was 9.1 ± 4.8 (SD, maximum 15) 30-min infusions with Tiprelestat and 7.8 ± 3.2 (maximum 14) with placebo. No relevant abnormalities in clinical or laboratory blood parameters were suspected to be caused by Tiprelestat. None of the Tiprelestat-treated patients developed severe COVID-19 (WHO Clinical Progression Scale ≥ 6). The number of days with any oxygen support tended to be lower in the Tiprelestat group (2.4 ± 3.6 days) compared to placebo (4.0 ± 6.2 days). Stable plasma trough levels of Tiprelestat were shown upon repeated administration for up to 7 days, even in patients with impaired renal function (eGFR > 31 to < 60 mL/min) as comorbidity.

CONCLUSION:

Tiprelestat infused for 30 min twice daily in patients with moderate COVID-19 requiring hospitalization was well tolerated and appears to be safe. Beneficially, plasma trough levels of the drug over time were high and stable. The small sample size does not facilitate reliable statements about efficacy. Further studies are necessary including other inflammatory severe respiratory diseases.

TRIAL REGISTRATIONS:

EudraCT 2022-000714-33, DRKS00031463.

News (Medical) associated with Tiprelestat(Proteo Biotech AG)

09 Dec 2024

·pipelinereview.com

tiakis Biotech AG Reports Clinical Phase Ib/II Trial Results of Tiprelestat for the Treatment of Hospitalized COVID-19 Patients

Tiprelestat was safe and well tolerated, with initial signs of clinical efficacy KIEL, Germany I December 9, 2024 I 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 ). 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. SOURCE: tiakis Biotech

Clinical ResultClinical Study

16 May 2023

·www.biospace.com

tiakis Biotech AG and Northway Biotech: Successful Tech Transfer and Expansion of Manufacturing Capabilities for Tiprelestat

KIEL, GERMANY / ACCESSWIRE / May 16, 2023 / tiakis Biotech AG (tiakis), in collaboration with its CDMO partner Northway Biotech, is pleased to announce the successful completion of a technology transfer and ramp-up of manufacturing capabilities for Tiprelestat, a pioneering anti-inflammatory and tissue-protective drug being developed for the prevention of postoperative inflammatory complications following major surgery, treatment of COVID-19 and pulmonary arterial hypertension. For the first time worldwide, a clinical trial is being supported by Tiprelestat study material produced at an industrial fermentation scale, representing a ten-fold increase in manufacturing potential to 3,000 L. tiakis Biotech AG and Northway Biotech collaboration tiakis Biotech AG and Northway Biotech: Successful Tech Transfer and Expansion of Manufacturing Capabilities for Tiprelestat "The marked increase in manufacturing capabilities lays the foundation for the next stage of tiakis' development programs, with the recent start of our COMCOVID phase Ib/II clinical trial being a prime example," said Martin Voss, tiakis Biotech AG co-CEO. The enhanced production capabilities is a result of the successful completion of a technology transfer and subsequent ramp-up program, achieved in a short time through close collaboration with end-to-end biologics CDMO Northway Biotech, based in Vilnius, Lithuania. Reflecting on this milestone, Vladas Algirdas Bumelis, CEO of Northway Biotech, stated: "The confidence our partners have placed in our two-decade-long expertise has enabled us to collaboratively scale up the process and meet tiakis' deadlines. Our state-of-the-art 3,000 L stainless-steel fermenter train was utilized to carry out the implementation successfully. We extend our sincere well-wishes to our partners as they move forward with their innovative drug through clinical trials, and we look forward to future collaborations." André Markmann, VP Business Development of Northway Biotech, added: "This partnership exemplifies our commitment to assist our partners in achieving their objectives by leveraging our technical expertise and operational capabilities. We are immensely proud to be part of this groundbreaking project, which addresses a significant unmet medical need." By attaining this pharmaceutical and technological milestone, tiakis and Northway Biotech have demonstrated their capabilities to pave the way towards groundbreaking achievements as pioneers in their respective fields. The success of this fast-paced project is characterized by strong collaborative interaction, mutual trust, and flexibility between the two companies. About Tiprelestat tiakis biopharmaceutical drug candidate Tiprelestat promises an excellent therapeutic benefit-risk pro use as an anti-inflammatory and tissue-protective drug. Tiprelestat is identical to the human protein elafin with high specificity for tissue-destroying and inflammation-promoting proteases. The development program of Tiprelestat is focused on the late-stage development of Tiprelestat in major surgery and early-stage development in pulmonary arterial hypertension (PAH) and COVID-19. About tiakis Biotech AG tiakis focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Tiprelestat for life-threatening surgeries and life-threatening diseases such as PAH and COVID-19. tiakis seeks partners and investors for the development, commercial-scale manufacturing, marketing and distribution of the product. The company tiakis Biotech AG is located in Kiel, Germany ( ). About Northway Biotech Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and in Waltham, MA, US. Further information can be found on Northway's website . Contact Information Vladas Bumelis CEO and Chairman of the Board vladas.bumelis@northwaybiotech.com SOURCE: Northway Biotech View source version on accesswire.com:

100 Deals associated with Tiprelestat(Proteo Biotech AG)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tiprelestat(Proteo Biotech AG)	-	DB05161

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Arterial Hypertension	Phase 2	United States	Stanford University	01 Jul 2026
Myocardial Reperfusion Injury	Phase 2	United Kingdom	tiakis BIOTECH AG	28 Jul 2011
Post procedural inflammation	Phase 2	Germany	-	18 Aug 2008
Lung transplant rejection	Preclinical	United States	Stanford University	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DRKS00031463 (COMCOVID, PipelineReview) Manual	Phase 1/2	COVID-19	17	Tiprelestat	jiklgojhnt(ztalrlqvuj) = ardxxzwwht oitscksinx (puwcbppbas, 3.6) View more	Positive	09 Dec 2024
				Placebo	jiklgojhnt(ztalrlqvuj) = ghbyeywohh oitscksinx (puwcbppbas, 6.2) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis