SUMMIT CLINICAL RESEARCH IN COLLABORATION WITH NAIL-NIT CONSORTIUM TO PRESENT GROUNDBREAKING DATA AT THE EASL CONFERENCE FROM OVER 5,000 PATIENTS COMBINED FROM MULTIPLE CLINICAL TRIALS

SAN ANTONIO, June 15, 2023 /PRNewswire/ -- Summit Clinical Research is pleased to announce the acceptance of 7 abstract presentations at the upcoming European Association for the Study of the Liver EASL 2023 Congress in Vienna, Austria, June 21^st – June 24^th. Summit Clinical Research will present 2 Oral presentations and 5 Poster presentations at the EASL Congress this year and feature the Summit Clinical Research Key Opinion Leaders, Dr. Stephen Harrison, Dr. Mazen Noureddin, Dr. Naim Alkhouri, Prof. Dr. Jörn Schattenberg, and Summit Clinical Research CMO, Dr. Sophie Jeannin Megnien.

These abstracts will provide insight on the screen failure hurdles in clinical trials, on society guidelines performance and population characteristics for the identification of at-risk NASH, and on the performance of non-invasive tests to predict severity of disease and histological features.

Dr. Mazen Noureddin, Professor of Medicine at Houston Methodist Hospital, Chief Scientific Officer of Summit Clinical Research, and Chair of the Steering Committee for NAIL-NIT Consortium, expressed enthusiasm about the recent abstracts being presented at EASL Congress 2023, stating, "The NAIL-NIT Consortium objective is to close the gap on non-invasive tests, by performing retrospective analyses to inform the field, and by developing a clinical prediction model to correlate non-invasive tests with major adverse liver outcomes. The ultimate goal is to improve the reliability of endpoints in NASH trials and to enable treatment decision making and follow-up in clinical practice, without the use of liver biopsy. This impressive dataset and analyses are the first step in providing robust results to the different stakeholders in NASH development."

The 2 Oral presentations and 5 Poster presentations being presented at the EASL Congress 2023 event are listed below:

2- Oral presentations at EASL Congress 2023

• OS-027: Performance of vibration controlled transient elastography and related scores to identify at-risk non-alcoholic steatohepatitis patients: combined data from multiple trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium), Date 22 June 2023, Presenter Dr. Mazen Noureddin.
• OS—026: Performance of the AGA clinical care pathway in identifying patients with at-risk non-alcoholic steatohepatitis: combined data from multiple therapeutic clinical trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium). Date 22 June, presenter Dr. Naim Alkhouri

5- poster presentations at EASL Congress 2023

• THU-413: Deep dive analysis into the screening failure reasons: combined data from multiple therapeutic clinical trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium). Date 22 June, presenter Prof. Dr. Jörn Schattenberg.
• THU-439: Glycated hemoglobin as an independent predictor of hepatocyte ballooning in non-alcoholic steatohepatitis: combined data from multiple clinical trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium). Date 22 June, presenter Dr. Stephen Harrison
• THU-438: The impact of glycemic control on progressive forms of non-alcoholic fatty liver disease: combined data from multiple clinical trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium). Date 22 June, presenter Dr. Mazen Noureddin
• THU-552: Comparison of non-alcoholic steatohepatitis severity between Hispanics and non-Hispanics: combined data from multiple therapeutic clinical trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium). Date 22 June, presenter Dr. Sophie Jeannin Megnien
• SAT-401: Performance of non-invasive tests as exclusion criteria for cirrhosis in trials targeting at-risk non-alcoholic steatohepatitis: combined data from multiple trials including more than 5,000 patients (in collaboration with NAIL-NIT Consortium). Date 24 June, presenter Dr. Naim Alkhouri.

About NAIL-NIT Consortium:

Leaders from Summit Clinical Research together with Key Opinions Leaders, Pharmaceutical Industry, Diagnostic Companies and Patient Advocacy groups have initiated a consortium (NAIL-NIT Consortium) with the main objective to design a prospective clinical trial to provide the body of evidence requested by the Food and Drug Administration (FDA) to use non-invasive tests as alternatives to liver histology in NASH clinical trials and for patients' standard of care management.

The NAIL-NIT Consortium has designed a multicenter prospective observational study to help better characterize the performance of noninvasive biomarkers to predict Major Adverse Liver Outcomes (MALO) in NASH. This study will develop and validate a clinical prediction model that leverages the optimal biomarker combinations.

About Summit Clinical Research:

Summit Clinical Research is an Integrated Research Organization which brings together experienced research sites with proven successes in the Non-Alcoholic Steatohepatitis (NASH) research space. Our mission is to execute comprehensive site recruitment and engagement strategy to achieve the target patient enrollment goal efficiently and cost-effectively, in the projected timelines. Summit Clinical Research is dedicated to advancing medical knowledge through rigorous clinical research. With a commitment to scientific excellence, patient safety, and quality data, Summit Clinical Research collaborates with pharmaceutical companies, Clinical Research Organizations, healthcare providers, and research institutions to conduct cutting-edge clinical trials across various therapeutic areas.

For more information about Summit Clinical Research and its ongoing initiatives, please visit https://summitclinicalresearch.com

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