World Sepsis Day 2024: Improved clinical trial design and targeted therapies remain key unmet needs: GlobalData

World Sepsis Day, which takes place annually on September 13, aims to raise awareness of the devastating condition that claims millions of lives globally each year. Sepsis is a life-threatening and complex disease caused by a dysregulated host immune response to an infection. Currently, there is no drug that specifically targets the underlying pathophysiological processes that cause sepsis. As such, improved clinical trial design for sepsis drug candidates and targeted therapies remain key unmet needs in this space, says GlobalData.

According to GlobalData, there are currently 14 drugs in late-stage development (Pre-registration, Phase II, and Phase III) for sepsis in the eight major markets (8MM*).

Anaelle Tannen, Infectious Disease Analyst at GlobalData, comments, “Enhancing awareness of sepsis is incredibly important, especially since the outcome of this disease is highly dependent on timely diagnosis and rapid initiation of therapeutics. Furthermore, there is a lack of funding in this area, and it is hoped that increasing awareness will encourage more investment in sepsis research.”

Sepsis can develop into septic shock, in which underlying circulatory, cellular, and metabolic abnormalities are profound enough that they can lead to multiple organ failure and death, especially if not recognised early and treated promptly.

Currently, treatment for sepsis relies on the rapid administration of antibiotics and fluid resuscitation in order to fight the infection and regain organ function, along with the use of vasopressors in order to correct for the persistent hypotension seen in septic shock, as well as other supportive care.

Tannen adds, “There is a big unmet need for drugs that specifically target sepsis, as currently only symptomatic treatments are available. A lack of understanding of the underlying pathophysiological processes contributes towards this issue.”

Key opinion leaders (KOLs) interviewed by GlobalData acknowledged that the high failure rate of drugs in sepsis clinical trials has created a sense of scepticism. Examples include Phase III trial failures for AM Pharma’s ReCAP (REVIVAL study) and Asahi Kasei’s thrombomolduin alfa (SCARLET study). KOLs believe that the failure in clinical trials is largely due to the use of inappropriate trial endpoints and recruiting heterogenous study groups.

Tannen concludes, “Increased use of artificial intelligence (AI) could help to address the issues with sepsis clinical trial design by identifying homogenous study populations via specific biomarkers and matching these patient subgroups to specific drugs under investigation. This could increase the likelihood of approval of certain drugs for the treatment of sepsis”.

*8MM = US, France, Germany, Italy, Spain, UK, Japan, and China