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R&D Trends: Sepsis - Improvements in clinical trial design and advances in biomarker research hold the key to a tailored approach to sepsis therapy
Datamonitor, April 2011, Pages: 40
Despite Eli Lilly’s Xigris being the only licensed therapeutic, the sepsis market remains commercially attractive due to its large patient population and high mortality rates. However, the complexities of the disease create a number of problems in clinical development, such as enrolment of appropriate patients, difficulties in demonstrating efficacy and a high rate of product failures.
Features and benefits
- Overview of the clinical pipeline for sepsis along with an assessment of the key R&D trends
- Analysis of current clinical trial design and its impact on drug development for sepsis
- Discussion of future clinical trial design and how it will evolve with improved understanding of the disease and advances in biomarker research
- Review of feedback from key opinion leaders on the future of sepsis therapy
Highlights
- The majority of R&D activity for sepsis focuses on attenuation of the systemic inflammatory response which characterizes the disease, with a number of novel targets being investigated. The pipeline shows promise, although only one product is in Phase III, meaning that new drugs remain several years from the market.
- Eli Lilly’s Xigris is currently the only marketed direct therapy for sepsis. However, its commercial performance has been disappointing due to efficacy and safety concerns and its restricted label. However, the sepsis market remains commercially attractive due to its large patient population, high mortality rates, and lack of market competition.
- In the long-term, physicians will most likely have a range of complimentary drugs at their disposal for treating sepsis. Combined with advances in biomarker research and their incorporation into diagnosis and therapy, this would aid the creation of a “personalized medicine” approach where therapy can be tailored to individual patients.
Your key questions answered
- Gain an insight into key trends in the pipeline and drug classes currently in development for sepsis
- Assess how future clinical trial design will better reflect the characteristics of sepsis and facilitate greater success in drug development
- Understand how new product approvals and developments in biomarker research will impact new treatment approaches
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