Research scientist Prof Steve Kerrigan and pharma entrepreneur Dr Ivan Coulter are the co-founders of Inthelia Therapeutics, a clinical stage biopharmaceutical company set to create a paradigm shift in the treatment of life-threatening sepsis.
Sepsis is a potentially fatal illness caused by a pathogen entering the bloodstream. Once it takes hold it begins attacking the lining of the blood vessels. If a patient’s immune system can’t muster a robust counterattack, the pathogen wins.
The successful treatment of sepsis depends on early intervention. Otherwise, the risk of mortality increases by 8 per cent every hour a patient is left untreated.
Current figures for Ireland indicate that 60 per cent of all in-hospital deaths have a sepsis or infection diagnosis while 42 per cent of hospital beds are occupied by patients with an infection or sepsis. As things stand, sepsis treatment is not optimal due to delayed diagnosis, heavy reliance on antibiotics and growing antimicrobial resistance.
“Sepsis affects approximately 49 million people every year and is responsible for about 11 million deaths. It currently ranks in the top three causes of adult hospitalisations and accounts for half of all hospital fatalities,” says Kerrigan, who is professor of precision therapeutics in the School of Pharmacy and Biomolecular Sciences at the RCSI (Royal College of Surgeons in Ireland.)
Having seen numerous attempts to tackle the escalating sepsis crisis fail, Kerrigan believed the solution was not more powerful antibiotics but a completely new type of drug therapy that would work alongside existing treatments. However, this meant turning the traditional approach to treating infection – killing the bugs causing it – on its head.
Kerrigan decided it was time to shift the focus away from the pathogens (who are very smart at evading attempts to zap them) and on to the host. The result is Cilengitide, a first of its kind host-targeted therapy designed to protect the host rather than kill the bugs.
The pathogens are still there but Cilengitide blocks or reverses their ability to bind to the host’s blood vessels. This stops the progression of the sepsis and limits its capacity to trigger serious illness and organ damage.
“Inthelia is focused on a fixed target whereas conventional antimicrobials focus on moving targets,” Kerrigan says. “Cilengitide has the potential to impede sepsis progression and even reverse its effects. It also mitigates concerns about antimicrobial resistance. We are also investigating a new biomarker which, if successful, will serve as an early warning signal that a patient is at risk of developing sepsis or is in the early stages.”
The origins of the research underpinning Cilengitide (which will have applications for other infections including Covid-19) go back to 2015, and bringing the drug to market came a step closer with the spin-out of Inthelia from the RCSI in 2021. Since then the company, which employs four, has been progressing its clinical studies.
Funding to date by way of research grants is €2.8 million and the next step is a pre-seed round of €2 million followed by a further round of €10 million to build the team and conduct inhuman trials.
“Our innovation is positioned at the convergence of two lucrative markets: the sepsis therapeutic sector which is expected to be worth $6.2 billion by 2028, and the sepsis diagnostic market, which is projected to grow to $1.6 billion by 2030,” Kerrigan says.
The company is expecting to get fast-track approval for Cilengitide from the FDA as sepsis costs US healthcare providers an estimated €25 billion a year and the US is not alone. Sepsis is a massive cost burden worldwide. All going smoothly, Cilengitide could be on the market within five years or less. That won’t be a moment too soon, says Kerrigan who adds that the spiking sepsis crisis is primarily a problem of human making due to the over-prescription and over-use of antibiotics.
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