Data suggest that SINTAX drugs may overcome blood-brain barrier limitations for anti-inflammatory drug delivery
–EDP1867 reduced the severity of the disease and the incidence of relapses in the murine model of multiple sclerosis–
–Data supports the development of EDP1867 for the treatment of neuroinflammatory diseases–
CAMBRIDGE, Mass., October 13, 2021 (GLOBE NEWSWIRE) – Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical phase biotechnology company developing SINTAX drugs as a new method for orally delivered treatments for inflammatory disease, today submitted preclinical data for EDP1867, a non-living pharmaceutical preparation of a single strain of Veillonella parvula, by ECTRIMS 2021, 13.-15. October, 2021. The data show that orally administered EDP1867 reduced the severity of the disease and the incidence of relapse in relapsing experimental autoimmune encephalomyelitis (EAE) mouse models of multiple sclerosis (MS), supporting the development of EDP1867 for the treatment of neuroinflammatory diseases.
“These data suggest that the small intestine, SINTAX, is an immune signaling portal for the central nervous system (CNS) that opens up a whole new pathway for the treatment of neuroinflammation,” said Mark Bodmer, PhD, President of R&D and Scientific Director of Evelo. “This striking observation shows that an orally delivered, intestinal-restricted SINTAX drug overcomes blood-brain barrier drug delivery limitations by utilizing the immunosensory connections between the small intestine and the CNS. This result complements our growing evidence in clinical and preclinical studies that SINTAX drugs have the potential to treat a wide range of systemic inflammatory conditions without systemic exposure. The observation that it extends to the CNS suggests the potential for SINTAX drugs in addition to the treatment of classic chronic inflammatory diseases to uninhibited neuroinflammation. ”
In the preclinical study presented at ECTRIMS, EDP1867 was tested in an EAE mouse model with relapsing neuroinflammation. Oral daily treatment with EDP1867 administered prophylactically or therapeutically reduced the severity of the disease as demonstrated by a reduced mean maximum score and a reduced incidence of relapse compared to placebo. Treatment with EDP1867 reduced inflammation and demyelination in the spinal cord as shown in histopathological analysis. Transcriptional profiling of small intestinal tissue confirmed that EDP1867 upregulated genes in lymphocyte pathways that resolve inflammation, as well as genes associated with intestinal homeostasis.
EDP1867 is a non-living pharmaceutical preparation of a single strain of Veillonella parvula, isolated from the ileum by a human donor. It is made non-living by y-irradiation in the manufacturing process, making it unable to colonize or persist in the intestine, a key feature of SINTAX medicine. EDP1867 is currently in clinical development. It has the potential to treat a wide range of inflammatory and neuroinflammatory diseases.
About Evelo Biosciences
Evelo Biosciences is a clinical phase biotechnology company developing orally delivered drugs designed to act on the small intestine, SINTAX ™, with systemic therapeutic effects. SINTAX plays a key role in the management of the immune system, metabolic and neurological systems. Evelo’s first product candidates are pharmaceutical preparations of single strains of microbes that have been selected because of their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe and affordable drugs to improve the lives of people with inflammatory diseases and cancer.
Evelo currently has four product candidates under development: EDP1815, EDP1867 and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo promotes additional product candidates in other disease areas.
This press release contains forward-looking statements within the meaning of the Private Securities Reform Act of 1995. All statements in this press release that do not relate to historical fact should be considered forward-looking statements, including statements about the development of EDP1867, the promise and the potential impact of EDP1867, the timing and plans of clinical trials and the timing and results of clinical trials readings.
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 performance to be materially different from future results, performance or performance expressed or implied by the forward-looking statements. , including, but not limited to, the following: the impact of the COVID-19 pandemic on our activities, including our preclinical and clinical trials and the continuity of our business; that we have suffered 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 long, costly and uncertain process of clinical drug development, including potential delays in regulatory approval, our reliance on third parties and partners to expand our microbial library, conduct our clinical trials, produce 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 with other pharmaceutical companies; problems with the protection of our patented technology and the confidentiality of our trade secrets; potential lawsuits or claims for infringement of third party intellectual property or challenges to the ownership of our intellectual property; that our patents are 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; the ability of our management and major shareholders to control or influence our business significantly; costs and resources to operate as a public company unfavorable or no analyst research or reports; and securities class lawsuits against us.
These and other important factors, discussed under the heading “Risk Factors” in our quarterly report on Form 10-Q for the three months ended June 30, 2021, and our other reports submitted to the SEC, may cause actual results to differ materially. from those indicated by the forward-looking statements in this press release. Such forward-looking statements represent management’s estimates at the date of this press release. Although we may choose 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 representative of our views from a date after the date of this press release.
Kendra Sweeney, 239-877-7474
Jessica Cotrone, 978-760-5622