Evelo Biosciences Presents Biomarker Data Demonstrating Anti-inflammatory Effects of EDP1815 in Psoriasis at the 2022 European Academy of Dermatology and Venereology (EADV) Congress
Evelo Biosciences, Inc. (Nasdaq: EVLO) recently presented encouraging data on EDP1815, its lead product candidate, during a Phase 2 clinical trial for psoriasis at the EADV Congress in Milan. The biomarker data revealed broad anti-inflammatory effects, showing that EDP1815 can resolve systemic inflammation safely. Furthermore, gene expression analysis indicated significant reductions in cytokine genes related to inflammation. Evelo is seeking feedback from health authorities to advance EDP1815 into registration trials for psoriasis, with responses expected by the end of 2022.
- Phase 2 clinical trial data for EDP1815 shows broad anti-inflammatory effects.
- EDP1815 demonstrated safety and tolerability comparable to placebo.
- Gene expression analyses indicate inflammation-resolving activity in disease tissues.
- Company engages with health authorities to advance EDP1815 into registration trials.
- Evelo has incurred significant losses and is not currently profitable.
- The lengthy and uncertain process of clinical drug development poses risks.
- Potential delays in regulatory approval may affect timelines.
- Dependence on third parties for clinical trials and manufacturing could pose challenges.
CAMBRIDGE, Mass., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, today presented biomarker data demonstrating the broad anti-inflammatory effects of EDP1815, the Company’s lead product candidate in inflammation, in a Phase 2 clinical trial in psoriasis. The data were presented in a poster at the 2022 EADV Congress in Milan, Italy.
“The combined clinical and biomarker data presented today confirmed that our groundbreaking SINTAX-based medicine EDP1815 can resolve systemic inflammation without systemic exposure and with safety and tolerability data comparable to placebo,” said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. “We are pleased to share these results with the clinical community as we advance EDP1815 into later stages of development for use in psoriasis and atopic dermatitis.”
In addition to the systemic inflammation resolution, skin biomarker data from the trial presented at the EADV Congress confirmed gene expression reductions in multiple disease relevant cytokine genes, suggesting inflammation resolving activity in disease tissues. Systemic biomarker analyses from samples taken in the Phase 2 trial confirmed generalized reduction of systemic immune reactivity consistent with re-establishing immune homeostasis. In addition to the already completed Phase 2 psoriasis trial, EDP1815 is being studied in a Phase 2 trial in patients with mild, moderate, and severe atopic dermatitis. The Company is engaging with health authorities in the United States and Europe to solicit feedback on the proposed plan for advancing EDP1815 into registration trials in psoriasis, with feedback expected by the end of 2022.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting 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 product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (EVs). Evelo’s vision is to create therapies that are effective, safe, well-tolerated, and affordable to improve the lives of the billions of people living with inflammatory diseases. The Company is developing EDP1815, currently in late-stage development for psoriasis and atopic dermatitis, and EDP2939, about to enter the clinic to treat inflammatory diseases. Evelo is also 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 including 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 and EDP2939, the promise and potential impact of our 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 period ended June 30, 2022, 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
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