Evelo Biosciences, Inc. · OTC:EVLO
Evelo Biosciences — Technical Presentation (August 2019)
24 slides from Evelo Biosciences's technical presentation, Aug 6, 2019
Slide 1: Broad Platform Opportunity and New Therapeutic Modality Supported by Positive Interim Clinical Data
Broad Platform Opportunity and New Therapeutic Modality Supported by Positive Interim Clinical Data EDP1815 Advancing to Phase 2 August 6, 2019
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including
Slide 3: Key Highlights
Key Highlights • Interim clinical data supports Evelo’s platform opportunity and vision • EDP1815 and EDP1066 were well tolerated • EDP1815 in psoriasis • Reduction in mean Lesion Severity Score vs. placebo • Consistent skin and blood immune cell biomarker responses • Advancing into Phase 2 in early
Slide 4: EDP1815 in Psoriasis
EDP1815 in Psoriasis 4
Slide 5: Targeting EDP1815 to Address Unmet Needs of Psoriasis Patients
Targeting EDP1815 to Address Unmet Needs of Psoriasis Patients Mild Moderate Severe 71% 22% 7% • Future opportunity to treat any stage of disease given differentiated profile of Evelo’s oral biologics • Initial focus on mild to moderate populations with potential to address over 3.5 millionof these
Slide 6: EDP1815 Low Dose Psoriasis Cohort
EDP1815 Low Dose Psoriasis Cohort • 12 patients with mild to moderate psoriasis • Randomized 2:1 (active:placebo) with 550mg dose (enteric capsule formulation) for 28 days; daily oral administration • Primary endpoint of safety and tolerability • EDP1815 was well tolerated with no overall difference
Slide 7: Secondary and Exploratory Endpoints Reported
Secondary and Exploratory Endpoints Reported • Lesion Severity Score • Cellular biomarkers from skin biopsies • Blood immune cell biomarkers of cytokine production 7
Slide 8: Lesion Severity Score is a Sensitive Clinical Measure
Lesion Severity Score is a Sensitive Clinical Measure • Clinical measure of disease change in psoriasis • Lesion Severity Score is a component of the PASI scoring system • Uses the same underlying changes as lesion severity element of the PASI score • Tracks an individual lesion across dosing period
Slide 9: Statistically Significant Reduction in Lesion Severity Score
Statistically Significant Reduction in Lesion Severity Score Mean change (+/- SE) in lesion severity score over dosing period 9
Slide 10: Patient Data Showed Reduction in Lesion Severity Score of 0-67%
Patient Data Showed Reduction in Lesion Severity Score of 0-67% 25% 0% Percent change in Group lesion severity score at −25% Placebo end of dosing period EDP1815 −50% −75% 1 2 3 4 5 6 7 8 9 10 11 12 ID 10
Slide 11: Reductions in Skin Cellular Biomarkers were Consistent with Improvement in Lesion Severity Score
Reductions in Skin Cellular Biomarkers were Consistent with Improvement in Lesion Severity Score • Psoriasis pathology is driven by epithelial hyperplasia • Reductions observed in basal Mean (+/- SE) change in basal epithelium mitotic epithelium mitotic counts across cell count over dosing period (c
Slide 12: Reduction in Blood Immune Cell Cytokine Production Indicative of a Systemic Anti-inflammatory Response
Reduction in Blood Immune Cell Cytokine Production Indicative of a Systemic Anti-inflammatory Response Changes over Dosing Period in Cytokine Production After Stimulation of Blood Immune Cells with Lipopolysaccharide • Reduction in systemic cytokine Increased Production Increased production consiste
Slide 13: Positive Interim Data for 1st Cohort Supports Advancing into Phase 2
Positive Interim Data for 1st Cohort with Low Dose Over 28 Days Supports Advancing into Phase 2 • EDP1815 was well tolerated with no overall difference reported from placebo • Statistically significant reduction vs. placebo in Lesion Severity Score • Reduction in Lesion Severity Score of 0-67% in pa
Slide 14: Planning for EDP1815 Phase and Indication Expansion
Planning for EDP1815 Phase 2 and Indication Expansion Placebo-controlled dose and formulation optimization study in mild to moderate psoriasis patients planned for early 2020 initiation • Primary endpoint: change in PASI score at 24 weeks • Interim analysis at 12 weeks Part A Part B Goal: Formulatio
Slide 15: Novel Formulation was Up to 30-fold More Potent Preclinically
Novel Formulation was Up to 30-fold More Potent Preclinically 15
Slide 16: EDP1066 in Psoriasis
EDP1066 in Psoriasis 16
Slide 17: Dose-dependent Response Observed in Phase 1b Clinical Trial
Dose-dependent Response Observed on Blood Immune Cell Cytokine Production in Phase 1b Clinical Trial • EDP1066 was well tolerated with no overall difference reported from placebo • Reduction in blood immune cell cytokines which indicates a pharmacodynamic response in patients at the high dose; no ef
Slide 18: Reduction in Blood Immune Cell Cytokine Production Indicate a Pharmacodynamic Response at High Dose
Reduction in Blood Immune Cell Cytokine Production Indicate a Pharmacodynamic Response at High Dose Changes over Dosing Period in Cytokine Production After Stimulation of Blood Immune Cells with Lipopolysaccharide • 3.3g EDP1066 dose group caused a Increased Production Increased decreased production
Slide 19: Next Steps for EDP1066
Next Steps for EDP1066 • Focusing current Phase 1b trial on investigating activity of new formulation in atopic dermatitis • Data from 24 patient atopic dermatitis cohort with new formulation expected early 2020 • No further development in psoriasis 19
Slide 20: Summary
Summary 20
Slide 21: EDP1815 Phase 2a 12-week Interim Data Expected in Late 2020
EDP1815 Phase 2a 12-week Interim Data Expected in Late 2020 Candidate 2019 2020 Phase 1b Phase 1b Phase 2a 12-week interim Psoriasis 5x dose Psoriasis & atopic dermatitis Psoriasis EDP1815 Original formulation New formulation Original and new formulation 4Q 2019 Early 2020 Late 2020 Phase 1b Atopic
Slide 22: Today's Highlights and Next Steps
Today’s Highlights and Next Steps • Interim clinical data supports Evelo’s potential platform opportunity and vision • Oral biologics acting on cells in the small intestine can modulate systemic immunology • Developing effective, safe and affordable medicines for major chronic diseases • EDP1815 - C
Slide 23: Broad Platform Opportunity and New Therapeutic Modality Supported by Positive Interim Clinical Data
Broad Platform Opportunity and New Therapeutic Modality Supported by Positive Interim Clinical Data EDP1815 Advancing to Phase 2
Slide 24: EVELO
EVELO
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