Evelo Biosciences Presents Data on EDP1815 Mechanism of Action and Supporting Ongoing Clinical Development for Inflammatory Diseases

CAMBRIDGE, Mass., Jan. 17, 2022 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced data for EDP1815, the Company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis. The data were presented in two posters on Saturday, January 15, 2022, at the 2022 Winter Clinical Dermatology Congress in Koloa, Hawaii.

“The data presented today build on the substantial evidence accumulated through our clinical and preclinical work, deepening our understanding of the mechanism by which EDP1815 drives its clinical effects. They explain how an oral, gut-restricted SINTAX medicine can interact with the immune system in the gut, leading to systemic inflammation resolution without immunosuppression or concerning side-effects,” said Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo. “We are particularly pleased to share these results with the clinical community as we progress EDP1815 into later stages of development for the treatment of psoriasis and atopic dermatitis, two inflammatory diseases that affect millions of people worldwide.”

Preclinical data from the studies presented at the Winter Clinical Dermatology Congress confirm that EDP1815 modulates systemic inflammation through its initial interaction with innate immune receptors, including TLR2, leading to downstream changes in circulating immune-cell phenotypes. In addition, the data demonstrate that preclinical effects in Th17 models translate into signs of clinical benefit in psoriasis, and that preclinical effects in Th2 models translate into signs of clinical benefit in atopic dermatitis, supporting further clinical development of EDP1815 in these indications. A Phase 2 study of EDP1815 in patients with mild to moderate psoriasis is ongoing, and a Phase 2 study of EDP1815 in patients with mild, moderate, and severe atopic dermatitis is expected to initiate dosing in the first quarter of 2022.

About EDP1815
EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from multiple independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation.

About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act on the small intestinal axis, SINTAX™, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The Company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases.

Evelo currently has three product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases. Evelo is advancing additional product candidates in other disease areas.

For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release 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 other product candidates, the timing of and plans for clinical trials, and the timing and results of clinical trial 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 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 three months ended September 30, 2021, 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 press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. 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 press release.

Contacts
Investors:
Kendra Sweeney, 239-877-7474
ksweeney@evelobio.com

Media:
Jessica Cotrone, 978-760-5622
jcotrone@evelobio.com