TargED Biopharmaceuticals Launches Phase 1 Trial for Innovative Stroke Treatment
TargED Biopharmaceuticals, a private biotechnology firm based in the Netherlands, is making significant strides in the field of thrombotic disease treatment with the recent administration of its lead compound, TGD001, to the first participant in a Phase 1 clinical trial. This clinical trial, which took place in Germany, is the stepping stone toward the introduction of a cutting-edge thrombolytic agent designed to tackle acute ischemic stroke (AIS) and immune-mediated thrombotic thrombocytopenic purpura (iTTP).
Thrombotic diseases, which lead to the formation of blood clots that obstruct blood flow, are major contributors to mortality and disability on a global scale. Particularly concerning is acute ischemic stroke, which accounts for approximately 90% of all strokes, resulting in an estimated 5 million deaths each year. Current treatment options, such as intravenous alteplase (tPA), have notable limitations, with up to 80% of AIS patients becoming ineligible due to the stringent time frames required for administration and the potential for adverse bleeding outcomes.
The promising TGD001 is a first-in-class 'fusion protein' that adopts a unique two-step mechanism to dissolve clots. This innovative approach not only targets clots of varying sizes but also minimizes the risk of excessive bleeding, a common concern associated with traditional thrombolytics. TGD001 is designed for rapid administration—via short or bolus injection—making it an excellent therapeutic option in emergency settings.
The initial Phase 1 trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics of TGD001 in healthy volunteers. The first safety data from this study are expected to be released by mid-2025. Following this, TargED plans to move forward with two key trials in the latter half of 2025: a Phase 2a trial in AIS patients and a Phase 1b trial in those with iTTP, for which TargED garnered EU Orphan Drug Designation in July 2024.
At the helm of TargED, CEO Kristof Vercruysse emphasized the monumental significance of this trial's start. He remarked, "The dosing of the first participant with our lead compound TGD001 marks a watershed in the treatment of thrombotic disorders. Rapid treatment options that are well tolerated and don’t heighten bleeding risks are paramount in reducing severe disability or fatality caused by thrombotic conditions."
Highlighting the impact of these conditions, Chief Scientific Officer Steven de Maat pointed out that acute ischemic stroke remains one of the leading causes of preventable death and disability worldwide, reiterating the urgency for improved treatments. He stated, "Despite advancements, 15% of patients diagnosed with iTTP do not survive, and half of those who do face ongoing health issues. TGD001 holds the potential to significantly enhance outcomes in both AIS and iTTP and possibly other thrombotic conditions."
This innovative medicine represents TargED’s efforts to transform the treatment landscape for thrombotic disorders. Their distinct approach combining antibody fragments with thrombolytic drugs is set to change the paradigm of how such diseases are managed, thus increasing the effectiveness of existing therapies and filling a critical gap in patient care.
If successful, TGD001 could redefine thrombolysis for various thrombotic disorders, ultimately saving lives and enhancing quality of life for thousands of patients facing these debilitating conditions.
Thrombotic diseases, which lead to the formation of blood clots that obstruct blood flow, are major contributors to mortality and disability on a global scale. Particularly concerning is acute ischemic stroke, which accounts for approximately 90% of all strokes, resulting in an estimated 5 million deaths each year. Current treatment options, such as intravenous alteplase (tPA), have notable limitations, with up to 80% of AIS patients becoming ineligible due to the stringent time frames required for administration and the potential for adverse bleeding outcomes.
The promising TGD001 is a first-in-class 'fusion protein' that adopts a unique two-step mechanism to dissolve clots. This innovative approach not only targets clots of varying sizes but also minimizes the risk of excessive bleeding, a common concern associated with traditional thrombolytics. TGD001 is designed for rapid administration—via short or bolus injection—making it an excellent therapeutic option in emergency settings.
The initial Phase 1 trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics of TGD001 in healthy volunteers. The first safety data from this study are expected to be released by mid-2025. Following this, TargED plans to move forward with two key trials in the latter half of 2025: a Phase 2a trial in AIS patients and a Phase 1b trial in those with iTTP, for which TargED garnered EU Orphan Drug Designation in July 2024.
At the helm of TargED, CEO Kristof Vercruysse emphasized the monumental significance of this trial's start. He remarked, "The dosing of the first participant with our lead compound TGD001 marks a watershed in the treatment of thrombotic disorders. Rapid treatment options that are well tolerated and don’t heighten bleeding risks are paramount in reducing severe disability or fatality caused by thrombotic conditions."
Highlighting the impact of these conditions, Chief Scientific Officer Steven de Maat pointed out that acute ischemic stroke remains one of the leading causes of preventable death and disability worldwide, reiterating the urgency for improved treatments. He stated, "Despite advancements, 15% of patients diagnosed with iTTP do not survive, and half of those who do face ongoing health issues. TGD001 holds the potential to significantly enhance outcomes in both AIS and iTTP and possibly other thrombotic conditions."
This innovative medicine represents TargED’s efforts to transform the treatment landscape for thrombotic disorders. Their distinct approach combining antibody fragments with thrombolytic drugs is set to change the paradigm of how such diseases are managed, thus increasing the effectiveness of existing therapies and filling a critical gap in patient care.
If successful, TGD001 could redefine thrombolysis for various thrombotic disorders, ultimately saving lives and enhancing quality of life for thousands of patients facing these debilitating conditions.
Topics Health）
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