Spherix Global Insights

May 05, 2021

Spherix Global Insights Finds That Pipeline Therapies for Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis Will Need to Strike a Balance Between Liver Fat Reduction, Fibrosis Improvement, and Patient Safety as They Seek FDA Approval

Aside from an in-depth evaluation of the current diagnosis and management of NAFLD/NASH, ten pipeline product profiles were evaluated by gastroenterologists and hepatologists to assess strengths, weaknesses, and physician receptivity

 EXTON, Pa., May 5, 2021 /PRNewswire/ — Spherix recently surveyed 99 US gastroenterologists and 23 hepatologists and conducted ten qualitative interviews to assess the current and future management of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The combination of qualitative and quantitative research included in the Market Dynamix™: NAFLD/NASH (US) service evaluates, in detail, the etiology of the condition, diagnostic and treatment trends, as well as reactions to potential therapies in development.

The need for pipeline therapies to obtain FDA approval and fill the existing gap in the market is evident, as the majority of physicians agree that there is a significant unmet need for treatment options in NAFLD/NASH. In a separate question regarding challenges in managing these diseases, “lack of an effective therapy” was mentioned more than any other challenge by surveyed physicians.

According to gastroenterologists and hepatologists, the most important attribute for NAFLD/NASH pipeline therapies is efficacy in fibrosis improvement and prevention. Qualitatively, physicians added that this reflects the urgent need to treat patients who are approaching the cirrhosis stage as a result of NASH. Another key pipeline attribute is efficacy in liver fat reduction, which triggered significant levels of discussion around which patients needed this therapy feature and whether combination therapy was the answer.

Along with evaluating potential drivers for agents in development, the Spherix report included in this new service assesses physician awareness of and familiarity with ten pipeline assets that have at least Phase 2 clinical data available. These pipeline therapies include:

  • Aldafermin (NGMBio)
  • Aramchol (Galmed Pharmaceuticals)
  • Efruxifermin (Akero Therapeutics)
  • Lanifibranor (Inventiva)
  • Namodenoson (Can-Fite BioPharma)
  • Pegbelfermin/BMS-986036 (BMS)
  • Resmetirom/MGL-3196 (Madrigal Pharmaceuticals)
  • Semaglutide (Novo Nordisk)
  • Tropifexor (Novartis)
  • VK2809 (Viking Therapeutics)

Current physician familiarity with pipeline therapies is generally low, as qualitative respondents clarified that they will invest more time in getting up-to-speed when clear winners emerge from the clinical trial process. Gastroenterologists and hepatologists engaged in a thorough review of these pipeline product descriptions (based on publicly available clinical information for each product). Quantitative data captured for these NAFLD/NASH pipeline therapies includes:

  • Most likely to prescribe NAFLD/NASH therapy (likelihood rating if FDA-approved)
  • Most preferred NAFLD/NASH pipeline therapy (ranking)
  • Reasons for ranking therapy number one
  • Number of patients who would be started on each number one ranked therapy
  • Patient severity/stages who are candidates for pipeline therapies
  • Physicians’ level of “warehousing” patients for FDA-eventual approved therapies
  • Awareness of combination therapies for NAFLD/NASH
  • Combination therapies for NAFLD/NASH physicians would like to see
  • Preference for combination therapies versus monotherapies for NAFLD/NASH

The quantitative and qualitative data included in Spherix’s Market Dynamix™: NAFLD/NASH (US) report indicate that the desire for an FDA approved therapy is apparent for both gastroenterologists and hepatologists. Of note, manufacturers appear to be aware of this unmet need, as the pipeline is currently quite crowded. As these manufacturers attempt to navigate the pipeline, this report provides insight and guidance on the current market as well as physicians’ opinions and desires for the future.

NAFLD/NASH represents just one of the emerging gastroenterological conditions introduced into Spherix’s gastroenterology offerings through the Market Dynamix™ service. Other conditions covered include eosinophilic esophagitis and celiac disease.

About Market Dynamix™
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift 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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