Leading scientists at the Heart Research Institute (HRI) have made a breakthrough 25 years in the making, identifying and developing a new anti-clotting drug that shows great promise in the treatment of stroke.
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.
HRI’s Thrombosis Group lead researcher, Professor Shaun Jackson said his team have already demonstrated in preclinical models that when combining this new anti-clotting drug with existing stroke therapies, blood flow to the brain can be improved, reducing and preventing brain injury.
“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.
“If successful, this discovery will be the first drug breakthrough for the treatment of stroke in more than three decades of research. It could minimise the cognitive and physical disabilities caused by stroke.”
The new drug belongs to a similar group of “blood thinners” known as antiplatelets, which include the likes of drugs such as aspirin, often used to treat 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.
Stroke is a leading cause of death and disability globally with 16 million people suffering strokes annually.
Approximately 85 per cent of strokes are ischaemic, caused by the blockage of an artery by a blood clot within the brain, reducing cerebral blood flow. If not resolved within a few hours, there can be irreversible brain damage.
“In stroke, time is brain. The longer it takes you to get treatment, the worse off you will be,” Prof Jackson warned.
“Many stroke victims are never able to return to their normal life. Some are unable to work, while others end up in nursing homes, no matter their age.
“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.
There is currently only a single treatment which dissolves blood clots in the acute phase of stroke, tissue plasminogen activator (tPA).
HRI Assoc Prof Simone Schoenwaelder said the problem is, only 10 per cent 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.
“When the anti-clotting drug is combined with tPA, it not only helps dissolve the stroke-causing blood clot more effectively, but it can stop the clot from reforming altogether by targeting different and complimentary 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.”
If successful, it will mean 90 per cent of stroke sufferers could now have increased options when it comes to treatment in those crucial 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.
Prof Jackson said advancements in technology and improvements to access to funding have seen their research expedited in recent years.
“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 anti-clotting 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 which is having a profoundly positive impact on the Australian medical research ecosystem."
2SM Super Radio Network, 14 July 2023. Listen directly to the radio story here.
ABC News, Breakthrough anti-clotting drug shows promise for treating strokes, 13 July 2023.
Nine News, A potentially life-saving drug developed to treat strokes, 13 July 2023.
3AW Melbourne, New clot-busting stroke drug to be trialled in Australia, 13 July 2023. Listen directly to the radio interview here.
Sunrise on Channel 7, 13 July 2023. Watch the video here.
Herald Sun, Promising Aussie drug could be next stroke breakthrough, front page, 13 July 2023.
Header image: Prof Shaun Jackson