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| 8-K - 8-K - Evelo Biosciences, Inc. | evlo-20210120.htm |
Complete Phase 1b Dataset: EDP1815 in Atopic Dermatitis January 20, 2021
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 statements concerning the development of EDP1815, the promise and potential impact of EDP1815 and our product candidates, the timing of and plans to initiate clinical studies of EDP1815 and our other product candidates, and the timing and results of any clinical studies or readouts. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our cash runway; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Any such forward looking statements represent management's estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. 2
Phase 1b clinical trial design Trial Summary • Double-blind, placebo-controlled trial of 24 patients • Mild and moderate atopic dermatitis*, randomized 2:1 (active : placebo) • 56 days of oral administration of enteric capsule formulation, follow-up at day 70 • Once daily • No active topical treatments, no requirement to use emollients 3 *Baseline Disease Severity Inclusion criteria: • IGA 2 or 3 • BSA 5-40% Mean baseline characteristics EDP1815 (n=16) Placebo (n=8) EASI 8.31 9.31 IGA 2.63 2.75
No topical therapies required for patients for >8 weeks • No topical steroids permitted at any point • Topical emollients permitted to be used only if the patient was already using regularly prior to entry into trial • Low rate of topical emollients use: • Placebo: 2 of 8 (25%) applied emollient regularly • EDP1815: 4 of 16 (25%) applied emollient regularly • Phase 2 and 3 trials would include at least daily emollient use 4
Improvements in EASI, IGA*BSA, and SCORAD at day 56 5 * Clinical Measure Treatment Difference at Day 56 EASI 52% (p=0.062) IGA*BSA 65% (p=0.022) SCORAD 55% (p=0.043)
EASI: 10/16 patients on EDP1815 improved at day 56 6 Patients (n=24)
44% of EDP1815 patients achieved EASI50 7 Clinical Measure Placebo EDP1815 EASI50 day 56 0/8 (0%) 4/16 (25%) EASI50 day 70 0/8 (0%) 7/16 (44%) EASI50 response at day 70 Placebo EDP1815 Intervention
IGA*BSA: 6 patients achieved a >50% improvement at day 56 with EDP1815 8 50% Improvement Patients (n=24)
Clinically meaningful improvements in Patient-Reported Outcomes at day 56, including itch and sleep 9 Patient-Reported Outcome EDP1815 Mean change, day 56 (mean % change per patient) Placebo Mean change, day 56 (mean % change per patient) DLQI (Dermatology Life Quality Index) –3.6* (-35%) –0.3 (+46%) POEM (Patient-Oriented Eczema Measure) –4.1* (-21%) +1.6 (+22%) *Mean improvement exceeded the minimally clinically important difference1,2 • EDP1815 led to improvement in itch across all measured scores at day 56 • EDP1815 led to improvement in sleep across all measured scores at day 56 1. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33. doi: 10.1159/000365390. Epub 2015 Jan 20. PMID: 25613671. 2. Schram ME, Spuls PI, Leeflang MM, Lindeboom R, Bos JD, Schmitt J. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012 Jan;67(1):99-106. doi: 10.1111/j.1398-9995.2011.02719.x. Epub 2011 Sep 27. PMID: 21951293.
Efficacy of oral EDP1815 in atopic dermatitis 10 Patient on once daily oral EDP1815 and no topical treatments: before and after (patient achieved EASI50 score) Before, day 0 After, day 56
Conclusions 1. Consistent results observed across all atopic dermatitis measures 2. Progressing into Phase 2 clinical trial in atopic dermatitis 3. EDP1815 has now shown clinical activity in both psoriasis and atopic dermatitis patients 11
Patient need in mild and moderate atopic dermatitis 12
Hundreds of millions of patients worldwide live with atopic dermatitis, most with no meaningful treatments “1 in 3 takes one or more hours per day to treat their AD” 13Atopic Dermatitis: Survey of 192 patients from the National Eczema Association, 2016 https://nationaleczema.org/in-your-words-survey-series “Lack of safe and effective treatments” 15-20% of children and 3-6% of adults worldwide1 are estimated to suffer from atopic dermatitis 1 Datamonitor Healthcare; DaVeiga, 2012; GBD, 2018; Nutten, 2015, National Eczema Foundation
14 SINTAX medicines potentially applicable across spectrum of inflammatory diseases- plan to capture full breadth in staged manner Th2 focused • Allergic bronchopulmonary aspergillosis • Allergic rhinitis • Bullous pemphigoid • Chronic spontaneous urticaria • Eosinophilic esophagitis • Eosinophilic granulomatosis with polyangiitis • Hypereosinophilic syndrome • Prurigo nodularis • Nasal polyps Th1 focused • Acne • Alopecia areata • Chronic obstructive pulmonary disease • Crohn’s disease • Giant cell arthritis • Hidradenitis suppurative • Inflammatory myopathies • Lichen planus • Sarcoidosis • Sjögren’s syndrome • Ulcerative colitis • Vitiligo • Scleroderma / Systemic sclerosis First wave of potential expansion programs Examples of potential second wave expansion programs Th17 focused • Crohn’s disease • Giant cell arthritis • Hidradenitis suppurativa • Inflammatory myopathies Proof of concept results from currently studied indications ATOPIC DERMATITIS • Improvement in atopic dermatitis vs placebo • Positive results provide basis for Phase 2b PSORIASIS • Reduction in skin lesions vs placebo in 2 cohorts • Systemic Inhibition of multiple inflammatory cytokines • Ongoing Phase 2b trial HUMAN KLH • >90% reduction in inflammation vs placebo • Sjögren’s syndrome • Systemic lupus erythematosus • Lupus nephritis • Psoriatic arthritis • Axial spondylarthritis* • Rheumatoid arthritis* • Axial spondylarthritis • Rheumatoid arthritis • Psoriasis* • Psoriatic Arthritis* • Asthma • Allergy *Simplified and non-exhaustive view of inflammation. Many inflammatory diseases are complex and involve multiple arms of the immune system
Pipeline is rich in anticipated near-term clinical catalysts 15 Candidate Catalyst EDP1815 Psoriasis 1Q 2021: Phase 1b tablet formulation trial initiation 3Q 2021: Phase 1b tablet formulation data 2Q 2021: Phase 2 interim data 2H 2021: Full Phase 2 dataset 1H 2022: Phase 3 initiation* EDP1815 Atopic dermatitis 3Q 2021: Phase 2 initiation 1Q 2022: Phase 2 interim data 2022: Phase 3 initiation* EDP1815–TACTIC-E COVID-19 EDP1815–Rutgers University COVID-19 2Q 2021: Phase 2/3 interim safety data and futility analysis 2Q 2021: Phase 2 data EDP1867 Atopic dermatitis 1Q 2021: Phase 1b initiation 4Q 2021: Phase 1b data EDP2939 Inflammation 2022: Phase 1b initiation EDP1908 Oncology 2022: Phase 1 initiation *Progression to Phase 3 dependent on positive Phase 2 data