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Promising New Anti-Clotting Drug Enters World-First Clinical Trials

After an arduous 25-year journey, esteemed scientists at the Heart Research Institute have achieved a significant milestone by discovering and formulating a novel medication for preventing blood clots. This ground-breaking advancement exhibits immense potential in revolutionising stroke treatment.

Photo: Heart Research Institute

The drug (TBO-309) has the potential to improve blood flow to the brain and reduce and/or prevent brain injury with the researchers beginning Phase II Clinical trials in 80 stroke patients in six leading hospitals across Australia. The study is sponsored by The George Institute, a leading independent global medical research institute with major centres in Australia, China, India and the UK, and an international network of experts and collaborators.

Professor Shaun Jackson, leader of the Thrombosis Group at the Heart Research Institute (HRI), has revealed that his team has successfully showcased in preclinical models the synergistic effects of combining the newly developed anti-clotting drug with existing stroke treatments. This combination has demonstrated significant improvements in brain blood flow, leading to a notable reduction in brain injury occurrence and prevention.

"If this drug can improve blood flow to the brain, without causing excessive bleeding, it could be a game changer in advancing the traditional methods of treating ischaemic stroke, improving the quality of life for thousands of stroke sufferers," Prof Jackson said.

The recently developed medication belongs to the category of antiplatelets, which are commonly referred to as "blood thinners." This group encompasses drugs like aspirin, frequently prescribed for the treatment of heart attacks.

"There’s consensus that to reduce the risk of heart attack in some patients, they should take an aspirin. This drug could be that for stroke," Prof Jackson said.

Every year, approximately 16 million individuals worldwide experience strokes, making it a prominent cause of both mortality and disability on a global scale.

Around 85 percent of strokes are classified as ischemic, resulting from the obstruction of an artery in the brain by a blood clot, leading to a reduction in cerebral blood flow. If not promptly addressed within a few hours, irreversible brain damage can occur.

“In stroke, time is brain. The longer it takes you to get treat­ment, the worse off you will be,” Prof Jack­son warned.

"We know people in rural parts of the country usually fare the worst, simply because of the time it takes to get treatment. Advance stroke care is only available in major hospitals. We think this drug can help balance the gap between rural and city health,” Prof Jackson said.

At present, tissue plasminogen activator (tPA) stands as the sole treatment available for dissolving blood clots during the acute phase of a stroke.

HRI Assoc Prof Simone Schoenwaelder said the problem is, only 10 percent of stroke victims are able to receive it.

“Our eureka movement was discovering this new anti-clotting drug could improve the function of tPA and reduce stroke injury,” she said.

By combining the anti-clotting drug with tPA, not only does it enhance the efficacy of clot dissolution in stroke cases, but it also plays a crucial role in preventing clot reformation. This is achieved by specifically targeting distinct and complementary components of the blood clot.

“The most excit­ing thing is it does so with­out an added risk of bleed­ing, which we know leads to more strokes, so this drug may help reduce risk of anoth­er stroke.”

A successful outcome would result in a significant expansion of treatment options for up to 90 percent of stroke patients during the critical first 12 hours

“The benefit of this novel anti-clotting drug is its unprecedented safety profile. Unlike aspirin and other antiplatelets on the market, its anti-clotting activity comes without the potentially devastating risk of bleeding which can lead to further brain damage and death,” Assoc Prof Schoenwaelder said.

While combination therapy delivers the greatest benefit, the drug could also have the potential to be beneficial to certain groups of patients without tPA, because it appears to be very safe.

Peter Bush, CEO of ThromBio, the clinical stage drug discovery company established to commercialise TBO-309, said that despite the unexpected delays in the manufacturing of the drug itself due to global events such as the Ukraine conflict limiting some essential rare earths, the process went smoothly, and generated new intellectual property.

“We worked closely with the manufacturer, a leading global group, to make the active part of the drug using cutting-edge technology known as chiral synthesis, so we can efficiently scale up volumes as global demand increases,” he said.

According to Professor Jackson, recent years have witnessed accelerated progress in their research, thanks to advancements in technology and enhanced access to funding.

“It’s taken 25 years to get to this point – starting in Box Hill Hospital in Victoria in the late 1990s, when we discovered the potential importance of this new class of anticlotting agents.

“Back then when we started, there were limited options to get money to fund the research. If we were starting now, we would be able to do it a lot more quickly, thanks to the advancement of technology, but also Federal government investment in helping to translate new discoveries from the lab into clinical trials, enabling us to more rapidly advance promising new therapies. Our Phase II stroke trial is supported by a $2.7 million grant from the Government’s Medical Research Future Fund, a $20 billion investment with is having a profoundly positive impact on the Australian medical research ecosystem.

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