Prof Steve Kerrigan, a research scientist, and Dr Ivan Coulter, a pharmaceutical entrepreneur, co-founded a biopharmaceutical firm called Inthelia Therapeutics. This clinical-stage enterprise aims to bring about a considerable transformation in the approach to sepsis treatment, a deadly infection that can occur when a pathogen invades the bloodstream, attacking vascular linings. Successful treatment hinges on initial prompt action, as each untreated hour enhances mortality risk by 8%.
Currently, official data from Ireland reveals that sepsis or infections are diagnosed in 60% of all hospital-related deaths, while 42% of occupied hospital beds are utilised by patients with a similar diagnosis. Present treatment methods are subpar due to late diagnosis, an excessive dependency on antibiotics, and mounting resistance to antimicrobials.
Each year, around 49 million people globally get affected by sepsis, leading to approximately 11 million fatalities. According to Kerrigan, an esteemed professor of precision therapeutics at the RCSI (Royal College of Surgeons in Ireland)’s School of Pharmacy and Biomolecular Sciences, sepsis is one of the top three reasons for adult hospitalisations and is the cause behind half of all hospital-related deaths.
Seeing several unsuccessful attempts at addressing the growing sepsis crisis, Kerrigan formulated the idea of a novel drug therapy that would work in conjunction with existing treatments instead of merely developing stronger antibiotics. This required an overhaul to the conventional method of treating infections – eliminating the causative bugs. Kerrigan’s innovative approach shifted the focus from the pathogens to the host itself.
Thus, Cilengitide was born, an innovative, first-of-its-kind treatment that prioritises the protection of the host over the elimination of the pathogens. These pathogens are still present, but the treatment impedes or reverses their potential to attach themselves to the host’s blood vessels, thwarting sepsis’ progression and reducing the risk of severe illness and organ damage.
Inthelia concentrates on static targets, a notable deviation from the typical behaviour of traditional antimicrobial agents, explains Kerrigan. Cilengitide presents an opportunity to not only obstruct the advancement of sepsis but potentially reverse its effects as well. In addition, it addresses the rising concern of antimicrobial resistance. Concurrently, an exploratory investigation into a novel biomarker is underway which may offer an early indication of a patient’s susceptibility to, or the commencement of, sepsis.
Cilengitide, science-backed and with potential applicability to conditions such as Covid-19, was resultant of research initiatives dating back to 2015. The process of commercialisation advanced when Inthelia, a start-up with a team of four, spun out from the RCSI in 2021, facilitating the continuity of clinical trials.
Having acquired €2.8 million through research grants, the next move foresees a pre-seed round amounting to €2 million. This will be accompanied by an additional €10 million round intended for team expansion and the execution of trials involving human subjects.
Kerrigan adds that their innovative approach is at the intersection of two profitable markets – the sector of sepsis therapeutics estimated to reach $6.2 billion by 2028, and the sepsis diagnostics market projected to expand to $1.6 billion by 2030.
The company looks forward to accelerated approval from the FDA for Cilengitide, given the significant sepsis-related costs of around €25 billion incurred by American healthcare providers annually. This financial toll is not confined to the US but is a global concern. Per the current trajectory, Cilengitide is expected to be commercially available in less than five years. Kerrigan emphasises the urgency of this, stating that the escalating sepsis problem, largely attributed to antibiotic over-prescription and misuse, needs immediate remedying.