Non-alcoholic steatohepatitis or NASH remains one of the most intensely researched diseases especially given the challenges clinicians face today with diagnosis and treatment. In fact, people with NASH do not often present with any symptoms and it’s estimated that less than 2 percent of patients know they have it. What’s more, there is no approved treatment for NASH.
Pharmaceutical and biotech companies around the world are seeking new ways to tackle this troubling disease. Today, on International NASH Day, Xtalks presents six engaging NASH webinars developed by experts leading this frontier. From optimizing patient recruitment for clinical trials to biomarkers in NASH drug development, watch these on-demand webinars by visiting the links provided.
1) Think Enrolling Your NASH Trial Will Be Easy? Think Again.
The prevalence of NASH is estimated to be up to 25 percent of the population in the developed world, yet fewer than two percent of people have even heard of it. This will become a monumental challenge for clinical trial enrollment. Moreover, awareness barely increases (up to six percent) among those most at risk for developing the chronic, potentially fatal condition. Finding patients to randomize into a clinical trial will require a multi-pronged approach: deep understanding of the patient journey, a full commitment to patient and community engagement, targeted, empathetic recruitment campaign messaging and smart, data-driven site support.
In this webinar, participants will learn about:
- Results of a proprietary insights study conducted with this at-risk patient population
- How low awareness among patients and healthcare professionals impacts clinical trial enrollment
- Patient journey insights to inform education and engagement strategies
- Campaign messaging strategies designed to maximize referrals
- Analytic-driven, site-level recruitment solutions
Xtalks Partner: Continuum Clinical
2) Detection and Monitoring in Fatty Liver Clinical Trials: The Role of Medical Imaging
Non-alcoholic steatohepatitis (NASH) is characterized by the presence of an abnormal accumulation of fat in the liver that can progress to cell injury and inflammation. Recent intervention studies have aimed to reduce the NASH-related metabolic stress and liver fat levels by decreasing the amount of lipid droplets in the hepatocyte, before inflammation and fibrosis become irreversible. Medical imaging is a powerful tool for measuring the effect of the intervention on liver fat. To incorporate effective imaging-based experiments into clinical trials for NASH, there are several factors to consider during the experimental design phase.
In this webinar, Scientific Director of MSK & More Medical Affairs at Bioclinica Dr. Mark Tengowski will discuss the following:
- Liver biology and metabolism basics, including the progression to non-alcoholic fatty liver disease (NAFLD) and NASH
- Use of non-invasive imaging to grade and monitor fatty liver diseases
- Measurements that are key for fat fraction analysis, inflammation and elastography
- Common imaging challenges and how to account for them
- Serum markers and their uses
Xtalks Partner: Bioclinica
3) Biomarkers in NASH Drug Development: Using Cytokeratin 18 as a Secondary Endpoint in Clinical Trials
Liver biopsy is still considered the “gold standard” for diagnosis of NASH, and histological endpoints are currently required by the FDA for approval of NASH drugs. However, liver biopsy has many drawbacks, including sampling error, cost, risk of complications, and patient acceptability. Because of these limitations and concerns regarding liver biopsy, non-invasive biomarkers are urgently needed not just to identify subjects with NASH, but also to determine their response to novel therapeutic agents.
Markers of hepatic injury or cell death such as cytokeratin 18 (CK18 or K18) and its caspase-cleaved fragment, cCK18, have been suggested as endpoints for early clinical drug trials where histological assessments are not feasible.
In this webinar, hear from three experts as they walk participants through:
- A brief introduction of NAFLD and NASH and the role of CK18 in these diseases
- An overview of CK18 in NASH clinical trials
- Bioanalytical validation of cCK18 for drug development
Xtalks Partner: Diapharma Group, Inc.
4) NASH Clinical Trials: Challenges and Considerations
Join Andrew Roche, PhD, a senior member of ICON’s NASH team, as he speaks about overcoming the challenges and considerations associated with NASH clinical trials and examines potential strategies to address these challenges during trial design or study execution.
Currently, there are no approved medicines to treat subjects with or at risk of developing NASH. However, a number of pioneering companies have taken up the challenge to address this unmet clinical need. One of the many challenges encountered during this process is the process of enrolling subjects into a clinical trial via utilization of centralized assessments of liver biopsy specimens. During the course of this discussion, ICON will share considerations that will aid cost-effective and timely enrollment of subjects.
Xtalks Partner: ICON plc
A recent study conducted by Syneos Health shows that patients lack an understanding of disease causes, implications, and prognosis. This is a large gap in the current standard of care which not only causes confusion and anxiety that impacts their ability to take charge of their own health but is also likely a limiting factor in clinical trial participation. Clinical trials should be incorporated into the current standard of care as an option for NAFLD patients while more robust clinical guidelines are developed. Sponsors have a significant opportunity to address important unmet needs for patients, even as their own research progresses to find new treatments.
This webinar will provide participants with a new real-world insight to better understand the trends and patterns associated with the typical journey of patients living with NAFLD.
- Gain insights into the NAFLD patient journey and perceptions
- Better understand specific factors impacting clinical trial participation
- Recognize informational, educational, and support needs of patients to help drive better trial performance
Xtalks Partner: Syneos Health
6) Navigating the Complexities of NASH Development: Valuable Insights from a Key Opinion Leader
In this webinar, medical and operations experts from Medpace will facilitate a Q&A session with Dr. Stephen A. Harrison, an experienced Key Opinion Leader (KOL) in NASH. The presenters will participate in an in-depth discussion on selected topics associated with NASH development as well as strategies and opportunities for researchers. Key questions that will be addressed include:
- Recruitment
- What are the current trends in successful NASH trial recruitment?
- How can differences in epidemiology and patient management paradigms in the US vs Europe be leveraged to improve recruitment?
- How can differences in NASH between Western and Eastern population reflect on patients’ suitability in early/late NASH trials?
- Imaging and Liquid Biomarkers
- What are the most successful current biomarkers in NASH clinical trials?
- Timing
- What endpoints should be considered at different stages of development in Phase 2-4 trials?
Xtalks Partners: Medpace, Pinnacle Clinical Research
With this knowledge in hand, the outlook for NASH patients looks brighter. Read more about the latest NASH news and register for upcoming webinars to stay on top of the latest in the industry.
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