Spherix Global Insights

August 08, 2022

Gastroenterologists’ Urgency in Treating Celiac Disease Increases as the Number of Viable Pipeline Candidates Dwindles, According to Spherix Global Insights

The recent loss of the only Phase 3 CeD pipeline candidate highlights the unmet need of suitable treatments for a patient population seeking alternatives to the gluten-free diet

EXTON, Pa., August 8, 2022 /PRNewswire/ — Spherix recently surveyed 100 US gastroenterologists and conducted eight qualitative interviews to assess the current and future management of celiac disease (CeD). The combination of both qualitative and quantitative research included in the Market Dynamix™: Celiac Disease (US) service evaluates the diagnostic and treatment trends emerging with the condition, as well as physician reactions to potential therapies in development.

The 2022 report reveals a greater sense of urgency from gastroenterologists compared to the general sentiment found in last year’s report. Indeed, nearly three-quarters of respondents in the 2022 survey say that their CeD patient load has increased in the past year, compared to only 15% in 2021.

Correspondingly, more than two-thirds of gastroenterologists indicate a high unmet need for new treatments options compared to 44% the prior year. This can likely be attributed (in part) to the discontinuation of 9 Meters’ larazotide, the only CeD drug in Phase 3 clinical trials, based on disappointing interim results.

Spherix’s report also identifies the many challenges in treating this patient population, beginning with diagnosis of the condition. Similar to last year’s report, gastroenterologists estimate two in five CeD patients go undiagnosed. This can result from a lack of patient symptoms or confusion with other diagnoses (such as IBS or IBD).

Currently, the sole treatment option for patients is the gluten-free diet (GFD), which also tests patients’ and physicians’ management of the condition. It is estimated that close to half of CeD patients struggle to adhere to a GFD for a variety of reasons, including poorly labeled food packages and difficulties abstaining from foods one would typically enjoy.

The recent news of larazotide’s discontinuation opens the doors of opportunity for current and future Phase 1 and Phase 2 CeD therapies to grab the first-to-market title – which historically bodes well for new agents in an untapped market. Spherix’s Market Dynamix™ service includes access to insights that assess physician awareness of and familiarity with five viable pipeline CeD assets that have clinical data available. These pipeline therapies include:

  • Latiglutenase (ImmunogenX)
  • PRV-015 (Provention Bio, Inc. with Amgen)
  • TAK-101 (Takeda Pharmaceuticals)
  • ZED-1227 (ZEDIRA GmbH)
  • KAN-101 (Anokion SA)

Gastroenterologists engaged in a thorough review of these pipeline product descriptions (based on publicly available clinical information for each product). Quantitative data captured for these CeD pipeline therapies include:

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

CeD represents just one of the emerging gastroenterological conditions included in Spherix’s gastroenterology offerings through the Market Dynamix™ service. Other conditions covered are eosinophilic esophagitis (EoE), primary biliary cholangitis (PBC), clostridioides difficile (C. diff), irritable bowel syndrome constipation (IBS-C), and non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH).

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.

All company, brand, or product names in this document are trademarks of their respective holders.