Spherix Global Insights

March 23, 2022

Could Microbiome-Based Therapeutics Fill the Unmet Need in Recurrent Clostridioides Difficile (C. Diff) Treatment? Spherix Investigates

While physicians express excitement surrounding products in the microbiome sector, current challenges with access to fecal microbiota transplants may translate into slow adoption

EXTON, Pa., March 23, 2022 /PRNewswire/ — Spherix recently surveyed 76 gastroenterologists and 26 infectious disease (ID) physicians (including 8 qualitative interviews between both specialists) to gain perspective on the current and future management of Clostridioides difficile (C. diff). Data captured in Spherix’s Market Dynamix™: Clostridiodes Difficile (US) service also examines the treatment and diagnosis trends of this indication.

Spherix’s analyses reveal that while physicians are not unfamiliar with treating C. diff, the expanded use of antibiotics among the aging US population has meant increased prevalence of this disease in the past several years. With this growth in population, there has been a rise in recurring infections and a resulting unmet need for new therapies. The demographics and limitations of existing options make C. diff an area worthy of investment for manufacturers with agents in the pipeline or for firms searching for investment and acquisition opportunities.

According to most physicians, the greatest challenge in managing C. diff is the prevention of recurrent infections, which reportedly occurs in at least one-fourth of patients. The unmet need for these patients, who can relapse in mere weeks after successful treatment of their initial episode, is high – as indicated by a majority of gastroenterologists and ID specialists.

Qualitative and quantitative responses included in the Spherix report demonstrate a clear movement towards therapies that address the microbiome. The majority of physicians agreed they are “very familiar” with using fecal microbiota transplant (FMT) for various gastroenterological conditions. In addition, nearly two-thirds agreed that FMT will “dramatically change the C. diff treatment paradigm over the next five years.” However, over half of respondents expressed difficulties obtaining FMT for the treatment of C. diff.

After reviewing product profiles for investigational C. diff agents, both specialist groups indicate interest with microbiome-based therapeutics, especially for cases of recurrent C. diff. FMT is currently used sparingly for C. diff treatment, but its efficacy and familiarity to physicians opens the door for future microbiome-based therapeutics.

Several physicians commented that the potential standardization inherent with the newly-developed capsule formulations of FMT represents significant progress over the currently lengthy process of testing and matching for patients to receive traditional FMT via colonoscopy or nasal tube. They also noted the considerable potential for lower cost (vs. procedure) and convenience for the patient.

Spherix’s Market Dynamix™ assesses physician awareness and familiarity with seven C. diff pipeline assets, including microbiome-based and other mechanisms of action that have at least Phase 2 clinical data that is publicly available. These agents include:

  • RBX2660 (Rebiotix)
  • SER-109 (Seres Therapeutics)
  • CP-101 (Finch Therapeutics)
  • VE303 (Vedanta Biosciences)
  • NTCD M3 (Destiny Pharmaceuticals)
  • Ridinilazole (Summit Therapeutics)
  • PF-06425090 (Pfizer)

Sampled gastroenterologists and ID specialists engaged in a thorough review of these product profiles and then provided feedback on the following:

  • Likelihood to prescribe each therapy to initial and recurrent C. diff patients (likelihood rating if FDA approved)
  • Most preferred pipeline therapy (ranking)
  • Advantages and limitations of each pipeline therapy (open ended)
  • Reasons for ranking each therapy as the most preferred (open ended)
  • Estimated number of C. diff patients who would be initiated on each most preferred therapy

C. diff is just one of the emerging gastroenterological conditions covered by Spherix’s Market Dynamix™ service, others include eosinophilic esophagitis (EoE), non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH), celiac disease (CeD), and primary biliary cholangitis (PBC).

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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