Spherix Global Insights

June 01, 2022

Diabetes-Related Mechanisms of Action Make Their Move as Several NAFLD/NASH Pipeline Therapies Inch Closer to the First-Ever FDA Approval

Ten NAFLD/NASH pipeline product profiles were evaluated by US gastroenterologists and hepatologists to assess strengths, weaknesses, and physician receptivity

 EXTON, Pa., June 1, 2022 /PRNewswire/ — Spherix recently surveyed 103 US gastroenterologists and 20 hepatologists, along with conducting eight qualitative interviews (including 2 KOLs and 6 clinical trial participants), to assess the current and future management of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

The combination of qualitative and quantitative research included in their Market Dynamix™: NAFLD/NASH (US) service evaluates, in detail, the diagnostic and treatment trends emerging with the conditions, as well as physician reactions to therapies in development.

The NAFLD/NASH market represents perhaps the largest opportunity among all gastroenterology treatment areas. Several factors identified in the report contribute to this:

  • Size – The median number of patients per year treated by respondents is 65 for NASH and 110 for NAFLD. It is estimated that 25% of all US adults have NAFLD and that 20% of these patients have NASH (5% of all US adults).1
  • Growth – Roughly half of gastroenterologists and at least three quarters of hepatologists project the number of NAFLD and NASH patients will increase over the next three years.
  • Undiagnosed population – Respondents estimate that between forty to fifty percent of NAFLD/NASH patients have not been diagnosed.
  • No approved options – There currently are no FDA-approved therapies to treat NAFLD or NASH.
  • Promising therapies – More than half the respondents rated themselves “likely” to prescribe four of the ten pipeline profiles they reviewed if those therapies were to be approved by the FDA.
  • Combination potential – One in five gastroenterologists and almost half of hepatologists are open to the potential of prescribing combination therapy to treat NAFLD or NASH.

Spherix’s Market Dynamix™ service assesses physician awareness of and familiarity with ten pipeline NAFLD/NASH assets that have at least Phase 2 clinical data available. To accommodate maximum exposure of potential pipeline therapies, six profiles were exposed to all 123 physicians, while four rotated so that only 30 respondents reviewed them. The pipeline therapies part of this assessment include:

  • Resmetirom (Madrigal Pharmaceuticals)
  • Aramchol (Galmed Pharmaceuticals)
  • Lanifibranor (Inventiva Pharma)
  • EDP-305 (Enanta Pharmaceuticals)
  • Icosabutate (NorthSea Therapeutics)
  • Semaglutide (Novo Nordisk)
  • Efruxifermin (Akero Therapeutics)
  • Namodenoson (Can-Fite Biopharma)
  • TVB-2640 (Sagimet Biosciences)
  • VK2809 (Viking Therapeutics)

Gastroenterologists and hepatologists engaged in a thorough review of these pipeline product descriptions (based on publicly available clinical information). Quantitative data captured for these NAFLD/NASH pipeline therapies includes:

  • Most likely to prescribe therapy (likelihood rating if FDA-approved)
  • Most preferred pipeline therapy (ranking)
  • Advantages of each pipeline therapy (open-ended)
  • Limitation of each pipeline therapy (open-ended)
  • Reasons for ranking each therapy number one
  • Estimated number of NAFLD and NASH patients who would be started on each number-one ranked therapy

These metrics in the Spherix report can help to identify where the NAFLD/NASH market is moving in terms of expectations for pipeline therapies and their mechanisms of action. For example, the American Gastroenterology Association (AGA) recently established a Critical Care Pathway (CCP) for diagnosing and managing NAFLD/NASH patients. That CCP included the targeting of type 2 diabetes patients as primary candidates for potentially developing NAFLD/NASH.

This revised approach also appears to be influencing gastroenterologists’ and hepatologists’ prioritization of the pipeline therapies with diabetes-focused mechanisms. Specifically, of four NAFLD/NASH therapies with two years of preference data in the report, the two NAFLD/NASH therapies with diabetes-focused mechanisms of action (GLP-1 and PPAR) saw the largest increase in ranking preference since last year’s report.

NAFLD/NASH represents just one of the emerging gastroenterological conditions introduced into Spherix’s gastroenterology offerings through their Market Dynamix™ service. Other conditions covered include eosinophilic esophagitis (EoE), primary biliary cholangitis (PBC), celiac disease (CeD), and clostridium difficile (C. diff).

About Market Dynamix™
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a change in basic assumptions within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Learn more about our services here.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

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