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)

229

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

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·Journal of Cystic Fibrosis

Elafin expression is regulated by CFTR-mutation and TGFβ1 in human bronchial epithelial cells

Article

Author: van Koningsbruggen-Rietschel, Silke ; Thomassen, Jan Christoph ; Alcazar, Miguel A Alejandre ; Vohlen, Christina ; Rietschel, Ernst

BACKGROUND:

Cystic Fibrosis (CF) lung disease is characterized by inflammation and progressive matrix remodeling. These processes are influenced by genetic modifiers such as Transforming Growth Factor β₁, (TGFβ₁₎ which is enhanced by an imbalance of proteases, e.g. neutrophile elastase (NE) and its inhibitor elafin. Elevated TGFβ₁ concentrations in sputum are linked to impaired lung function in people with CF (pwCF); and decreased elafin levels in sputum are associated with P. aeruginosa infection. The direct influence of CFTR-mutations and the impact of TGFβ₁ on the expression of elafin has not yet been examined. Therefore, we investigated (1) the direct impact of the CFTR-mutation itself on elafin expression, (2) the interaction of TGFβ₁ and CFTR-mutation on elafin expression, and (3) the effect of inhibiting TGFβ₁ on the expression of elafin in human bronchial epithelial cells (HBE).

METHODS:

(1) Gene expression of elafin was measured by qRT-PCR and ELISA in CFTR-diseased (delF508 homozygous; CF-DHBE) and wildtype HBE cells (NHBE). (2) CF-DHBE and NHBE were stimulated with TGFβ₁ or vehicle and finally (3) TGFβ₁ was inhibited by Pirfenidone/SB43. Gene expression of elafin and inflammatory mediators, as well as inhibitors of proteases were analyzed by qRT-PCR or immunoblot.

RESULTS:

(1) mRNA and protein expression of elafin is significantly reduced in CFTR-mutated HBE when compared to NHBE cells. (2) Furthermore, the expression of elafin is inhibited by the genetic modifier TGFβ₁. (3) Inhibition of TGFβ₁ induced elafin expression in CF-DHBE cells and abrogated the CFTR- TGFβ₁ mediated inhibitory effect in HBE.

CONCLUSIONS:

Our study shows that CFTR-mutation itself mediates effects on the homeostasis of proteases by reducing the expression of elafin. Furthermore, the exposure to high TGFβ₁ concentrations increases the CFTR-mutation mediated reduction of elafin expression. Restoring elafin levels and/or inhibiting TGFβ₁ might be possible therapeutic options to reduce pulmonary inflammation and remodelling in CF.

01 Nov 2025·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Elafin inhibits macrophage activation by blocking a chloride channel

Article

Author: Wang, Feng ; Cui, Xiaoli ; Chen, Na ; Chen, Longxin ; Li, Xia ; Xu, Liang

The molecular mechanisms underlying the anti-inflammatory functions of elafin, beyond its role as a serine protease inhibitor, have garnered significant interest. In this study, we engineered an antibody-elafin fusion construct (Her-elafin) by grafting elafin into the complementarity-determining region (CDR) of the Herceptin antibody. Her-elafin retained the full inhibitory activity of elafin against neutrophil elastase and effectively suppressed lipopolysaccharide (LPS)-induced macrophage activation. Using Her-elafin as a molecular probe, we identified that elafin specifically binds to and inhibits Clic1, a chloride channel expressed on macrophages. This binding likely reduces intracellular reactive oxygen species (ROS) production, thereby attenuating downstream inflammatory cascades. Furthermore, the dual inhibitory activities of Her-elafin against neutrophil elastase and Clic1 resulted in significant anti-inflammatory effects in a murine model of acute lung injury, highlighting its potential as a promising therapeutic strategy.

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.

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Indication	Highest Phase	Country/Location	Organization	Date
Myocardial Reperfusion Injury	Phase 2	United Kingdom	tiakis BIOTECH AG	28 Jul 2011
Post procedural inflammation	Phase 2	Germany	-	18 Aug 2008
Pulmonary Arterial Hypertension	Phase 1	United States	-	18 Mar 2019
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	ldwdezrhvf(rtcbxsakdh) = odjgbfuciv oddqotdgqw (vqpdcepiom, 3.6) View more	Positive	09 Dec 2024
				Placebo	ldwdezrhvf(rtcbxsakdh) = dtzafpxpoq oddqotdgqw (vqpdcepiom, 6.2) View more

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