Evelo Biosciences, Rutgers University, and Robert Wood Johnson University Hospital Announce Submission of IND for a Phase 2 Study of EDP1815 in COVID-19 Patients
—Early intervention in hospitalized patients could help prevent progression of disease—
—EDP1815 has demonstrated favorable tolerability and anti-inflammatory activity in a prior clinical trial—
—Data expected during 2H 2020—
—Evelo Management to hold conference call today at 8:30 a.m. ET—
“Early intervention is essential to help prevent the progression of COVID-19, which, if left untreated, can result in the need for ventilators, intensive care, and in some cases, death,” said
“If early intervention with an oral anti-inflammatory agent such as EDP1815 is proven effective, it could help COVID-19 patients before severe complications emerge, mitigating the course of the disease, lessening patient morbidity and mortality and reducing the demand on hospitals,” said
Scientific and Clinical Rationale for EDP1815 in COVID-19
The progression to severe COVID-19 is associated with hyperinflammation, including cytokine storm. Based on data from a Phase 1b clinical study, EDP1815 has the potential to modulate multiple immune pathways associated with cytokine storm to resolve inflammation without causing complete immunosuppression.
In a Phase 1b clinical study in psoriasis, EDP1815 was observed to blunt the production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1b, and was well tolerated with no overall difference from placebo. In preclinical models, EDP1815 has been observed to have effects on Th1, Th2, and Th17 pathways, including TNF, IL-4, IL-5, IL-6, IL-12p40, IL-13, and IL-17. Several of these cytokines have been implicated in the cytokine storm associated with severe complications of COVID-19. In these models, no activity was observed on type 1 interferons, which are important for anti-viral responses.
If EDP1815 is approved for COVID-19, Evelo could rapidly scale its manufacturing to supply the drug at a reasonable cost. Additionally, if this Phase 2 is successful in COVID-19, Evelo plans to investigate EDP1815 as a potential therapy for other diseases such as influenza in which hyperinflammation and cytokine storm play a key role.
Conference Call Information
Evelo will host a live conference call and webcast today,
About Rutgers Biomedical and Health Sciences
About Robert Wood Johnson University Hospital New Brunswick
Evelo currently has four product candidates: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases, and EDP1503 for the treatment of cancer. Evelo is also advancing additional oral biologics through preclinical development in other disease areas.
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 EDP1815’s ability to treat patients with COVID-19 and other diseases, the timing of trials and results of data involving EDP1815 for the treatment of COVID-19, our development plans and the promise and potential impact of any of our monoclonal microbials or preclinical or clinical trial data.
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 business and operations, including our preclinical studies and clinical trials, and on general economic conditions; 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 Annual Report on Form 10-K for the fiscal year ended
Source: Evelo Biosciences, Inc.