Complimentary Webinar: CK18 – the Key to Unlocking Informed Decisions in MASH Drug Trials

Posted: April 15, 2024

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You’re Invited: Complimentary Webinar

CK18 – the Key to Unlocking Informed Decisions in MASH Drug Trials

Are the Arrows Pointing in the Right Direction? CK18 Biomarkers Can Provide Insight into Your MASH Drug Candidate’s Future Success

Tuesday, April 23 at 1 pm EDT


When: Tuesday, April 23 at 1 PM EDT

What: Metabolic-associated steatotic liver disease (MASLD, formerly known as NAFLD) is the most common form of chronic liver disease in developed countries. MASLD affects over 38% of the population worldwide and its prevalence is projected to grow to over 55% by the year 2040.

Individuals that have progressed to the more advanced form of this disease, metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH), are at an increased risk for liver-related complications such as cirrhosis and hepatocellular carcinoma (HCC), as well as other serious health problems.

While the recent FDA accelerated approval of the first pharmacologic therapy for MASH, Rezdiffra® (resmetirom), marked a truly historic milestone, many more drugs with diverse mechanisms of action are currently in development – with new candidates entering into pipelines every day – to address this complex and etiologically diverse disease. Improvements in liver histology confirmed through biopsy continue to be required endpoints for regulatory approval, however, non-invasive biomarkers may be used in early-stage trials to assess treatment effects.

Serum Cytokeratin 18 (CK18), measured by the PEVIVA® M30® Apoptosense® and M65® ELISAs, is a biomarker that has been included as a secondary and exploratory endpoint in over 70 clinical trials of drug candidates that are targeting MASH. CK18 levels are reflective of hepatocyte apoptosis and necrosis, which are thought to be important processes involved in the progression of MASH. Monitoring serum CK18 levels, therefore, provides mechanistic information on the effect of drug treatment in MASH clinical trials. Furthermore, decreases in serum CK18 levels have been shown to be reflective and predictive of improvements in liver histology.

The aims of this talk are to:

  1. Introduce the audience to the growing epidemic of MASLD
  2. Elucidate challenges in developing therapies for the treatment of MASH
  3. Provide an overview of CK18 and its role in MASH pathogenesis
  4. Present data that support the value of CK18 as a biomarker for assessing the efficacy of drugs in MASH clinical trials.


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