Objective: Assess familiarity with microbiome-based therapies

Q1. How would you rate your familiarity with microbiome therapies?

Very familiar9
Moderately familiar11
Slightly familiar5
Not familiar0
→ 80% (20/25) have moderate to high familiarity → Indicates strong baseline awareness among KOLs

Objective: Evaluate belief in therapeutic value

Q2. How promising are microbiome therapies across indications?

Highly promising14
Moderately promising8
Slightly promising3
→ 88% positive sentiment → Strong confidence, especially in GI disorders and emerging systemic applications

Objective: Identify priority disease areas

Q3. Which indications show the most promise? (Multiple responses allowed)

C. difficile infection22
Inflammatory bowel disease (IBD)18
Oncology (adjunct therapy)12
Metabolic disorders10
Neurological disorders6
→ C. difficile dominates as established use case → IBD and oncology seen as high-growth areas

Objective: Understand safety concerns

Q4. How do you perceive the safety of microbiome therapies?

Very safe6
Generally safe with concerns15
Significant safety concerns4
→ 76% see therapies as safe but with caution → Key concerns: long-term effects, off-target microbiome changes

Objective: Gauge trust in regulatory pathway

Q5. How clear is the regulatory pathway in the U.S.?

Very clear3
Somewhat clear12
Unclear10
→ 40% perceive regulatory uncertainty → Seen as a barrier to broader adoption

Objective: Measure likelihood of clinical use

Q6. How likely are you to prescribe/recommend microbiome therapies?

Very likely10
Likely9
Neutral4
Unlikely2
→ 76% willing to adopt → Adoption tied to stronger clinical evidence

Objective: Identify evidence requirements

Q7. What level of evidence is needed for routine adoption?

Large Phase III trials17
Real-world evidence13
Mechanistic understanding9
→ Clinical trial data is the primary driver → Real-world data also highly valued

Objective: Identify challenges to adoption

Q8. What are the biggest barriers? (Multiple responses)

Limited long-term data19
Regulatory ambiguity15
Manufacturing consistency14
Cost/reimbursement11
→ Evidence gap is the #1 barrier → Followed by regulatory and production challenges

Objective: Understand how crowded/competitive the field is

Q9. How competitive is the microbiome therapy space?

Highly competitive8
Moderately competitive13
Early-stage4
Seen as emerging but increasingly competitive

Objective: Capture long-term expectations

Q10. What is your outlook for microbiome therapies?

Transformational11
Significant niche role10
Limited impact4
→ 84% expect meaningful clinical impact → Split between "transformational" vs "targeted/niche"

Key Insights

High awareness + strong optimism among U.S. KOLs
C. difficile = anchor indication, validates platform credibility
Evidence and regulation = key bottlenecks
Adoption likely to accelerate with Phase III success and clearer FDA pathways
Field transitioning from experimental → clinically credible
Thought Leadership

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