GlobalData emphasises importance of improved clinical trials.

World Sepsis Day, observed annually on 13 September, aims to raise awareness about sepsis, a life-threatening condition that claims millions of lives each year.

Sepsis results from a dysregulated immune response to infection, and currently, no drugs specifically target its underlying causes. GlobalData, a leading data and analytics company, stresses the need for improved clinical trial designs and targeted therapies to address this gap.

According to GlobalData, 14 drugs are in late-stage development for sepsis across eight major markets.

Anaelle Tannen, an Infectious Disease Analyst at GlobalData, highlights the importance of timely diagnosis and rapid treatment initiation for better outcomes. She also notes the lack of funding in sepsis research and hopes increased awareness will drive more investment.

Sepsis can escalate to septic shock, leading to multiple organ failure and death if not promptly treated. Current treatments focus on antibiotics, fluid resuscitation, vasopressors, and supportive care. Tannen points out the urgent need for drugs that specifically target sepsis, as existing treatments only address symptoms.

Key opinion leaders interviewed by GlobalData acknowledge the high failure rate of sepsis drugs in clinical trials, attributing it to inappropriate trial endpoints and heterogeneous study groups.

Notable failures include AM Pharma’s ReCAP and Asahi Kasei’s thrombomodulin alfa trials.

Tannen reflected: “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.”

Improved trial designs and targeted therapies are essential to overcoming these challenges and improving sepsis treatment.