Spherix Global Insights

March 24, 2021

Upcoming Oral, Small Molecule Agents Have the Potential to Leapfrog Existing Biologic Treatment and Become Foundational Inflammatory Bowel Disease Therapies

Six pipeline product profiles were evaluated by current inflammatory bowel disease treaters to assess strengths, weaknesses, and potential prescribing levels in the context of the current treatment algorithm

 EXTON, Pa., March 24, 2021 /PRNewswire/ — Spherix recently surveyed 100 US gastroenterologists and followed up with seven qualitative interviews (including an industry key opinion leader) in order to assess the current pre-advanced systemic treatment algorithm for inflammatory bowel disease (IBD), along with the prospects for several oral, small molecule pipeline therapies. This new Special Topix™ service was created in response to the three oral, small molecule therapies currently in Phase 3 development for the treatment of IBD and the additional three therapies with Phase 2 clinical data.

Through ongoing research provided in Spherix’s core services offered in IBD, Spherix experts began to notice a possible paradigm shift in the way gastroenterologists are perceiving upcoming pipeline agents and how they intend on prescribing to biologic-naïve patients. The combination of qualitative and quantitative research included in the Special Topix™ service evaluates, in detail, the current treatment algorithm for pre-advanced systemic therapies, the decision point at which IBD patients are switched to biologics, and key physician reactions to oral, small molecule therapies in development.

Gastroenterologists in the survey reported that their most common first-line treatments for IBD are aminosalicylates and systemic corticosteroids, though this varied somewhat between ulcerative colitis and Crohn’s disease patients. Additionally, respondents reported that they typically make at least two adjustments (dosing changes) to their first-line selection before making a change to another treatment option. If these adjustments didn’t provide a response or remission for the patient, a majority of gastroenterologists indicated they will transition the patient to a biologic therapy. Usage of specific brands and generics of immunomodulators, aminosalicylates, and systemic corticosteroids are also evaluated in the report.

The study results revealed that the transition to biologics can sometimes be a challenge for gastroenterologists and their patients. Fear of side effects and concerns about safety are leading barriers for IBD patients starting biologic therapy. Insurance coverage and fear of shots/injections/infusion are also commonly cited barriers for patient conversion to biologics.

Prospects for oral, small molecule therapies currently in development are also captured in the full report. After assessing awareness of and familiarity with each of the six oral, small molecule pipeline assets, physicians were asked to review product descriptions (based on publicly available clinical information for each product). The therapies either had at least some Phase 2 clinical data or contained Phase 3 clinical results. These pipeline therapies included:

  • Zeposia – ozanimod (BMS)
  • Etrasimod (Arena Pharmaceuticals)
  • Rinvoq – upadacitinib (AbbVie)
  • Filgotinib (Gilead)
  • ABX-464 (Abivax)
  • BT-11 (Landos Biopharma)

The service includes access to qualitative feedback on each pipeline profile, along with an evaluation of likelihood to prescribe, advantages, limitations, and ranking of preferred therapies. One-third of gastroenterologists estimated they are “very likely” to prescribe these pipeline therapies before biologics, assuming two years of successful prescribing post-FDA approval. However, nearly all gastroenterologists qualitatively caveated that pricing and corresponding insurance coverage will be integral to that paradigm shift in prescribing.

The ranking exercise for these six profiles revealed gastroenterologists considered not only clinical factors but also practical issues, such as the likelihood of good insurance coverage based on each manufacturer’s legacy in that regard. At least three separate mechanisms of action (MOA) were represented by the competitive set of these therapies, but no single MOA dominated the ranking exercise, as physicians expressed an interest in having “a diverse set of tools in the toolbox.”

To supplement the findings in the report included in the Special Topix™: Pre-Advanced Systemic Therapies in IBD (US) service, Spherix will continue to monitor gastroenterologists’ awareness and receptivity to these pipeline therapies in both the US and EU markets via their RealTime Dynamix™ service offered on a quarterly and semiannual basis in those areas, respectively.

About Special Topix™
Special Topix™: Pre-Advanced Systemic Therapies in IBD (US) is an independent service that adds to Spherix’s coverage of the treatment of IBD patients by focusing on the treatment algorithm prior to the use of biologics. This perspective is vital as a wave of oral, small molecule pipeline therapies are poised to potentially leapfrog existing biologic treatment and become foundational IBD therapies. The assessment of the potential for each of these oral, small molecule therapies is included in the analysis of this report.

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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