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Milestones Achieved: PEI Approval and First Participant Dosed in TGD001 Phase 1 Study

At SCIRENT, we are excited to work for TargED Biopharmaceuticals B.V. in developing TGD001, an innovative thrombolytic therapy for thrombotic diseases. 

PEI Approval in Record Time

In October 2024, TargED Biopharmaceuticals B.V. received approval from the Paul-Ehrlich-Institut (PEI) for a First-in-Human study in Germany. This approval was granted in just 58 days, showcasing the importance of precise planning and streamlined processes in navigating the complexities of clinical trial regulations.

This success resulted from exceptional teamwork across Regulatory Affairs, Clinical Operations, Project Management, Protocol Development, and Medical Writing.

The PEI approval was a crucial milestone, particularly as First-in-Human studies represent the most sensitive and high-risk clinical research phase. TGD001, an innovative drug candidate, has the potential to revolutionize the treatment of a wide range of thrombotic diseases.

The First Participant Successfully Dosed

Building on this success, the first participant in the Phase 1 study was successfully dosed on December 18, 2024. This marks a significant step forward in the clinical development of TGD001.

This randomized, double-blind, placebo-controlled, single-ascending dose study, conducted in Germany, aims to evaluate the safety, tolerability, and pharmacokinetics of TGD001 in healthy volunteers. The first safety readout is expected by mid-2025.

TGD001: A Breakthrough in Thrombolysis

TGD001 is a pioneering thrombolytic therapy capable of dissolving blood clots of all sizes and compositions without increasing the risk of bleeding. Its unique two-step mechanism involves targeting blood clots through an antibody fragment that binds to von Willebrand Factor (VWF), followed by activation of an enzyme system that degrades VWF and fibrin – two key components of thrombi.

Unlike current thrombolytics, which often have significant limitations, TGD001 is tested to be a faster, safer, and more effective treatment option. Key future applications include:

·      Acute Ischemic Stroke (AIS): A leading cause of disability and death worldwide. TGD001 could extend the treatment window and improve outcomes for a broader range of patients.

·      Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP): A rare and life-threatening disorder where TGD001 can potentially resolve clotting episodes, saving lives and preventing complications rapidly.

Collaboration with TargED Biopharmaceuticals

SCIRENT and TargED are already preparing a Phase 2a study in AIS patients, set to begin in the second half of 2025.

A Promising Future for Clinical Research

These milestones demonstrate that Europe remains a competitive clinical research hub despite its complex regulatory landscape.

We are proud to be part of this journey to advance medical science and provide better treatment options for patients worldwide.


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For more information about TargED Biopharmaceuticals and TGD001, please visit their website.

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