Evelo Biosciences Announces EDP1815 to Advance into Phase 2/3 TACTIC-E COVID-19 Trial
—Phase 2/3 platform trial sponsored by Cambridge University Hospitals
—Experimental therapies with potential to prevent and treat complications of COVID-19—
—EDP1815 selected as one of two experimental therapies in the trial—
—EDP1815 has been observed to have favorable tolerability and anti-inflammatory activity in a prior clinical trial—
—Interim data expected in fourth quarter of 2020—
TACTIC-E is a Phase 2/3 randomised trial which will evaluate up to 469 patients per arm at Addenbrooke’s Hospital and other leading
Interim data from the trial are anticipated during the fourth quarter of 2020. If the Phase 2/3 data are positive, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration.
“The recent results with dexamethasone suggest that an oral agent, such as EDP1815, with potentially broad anti-inflammatory effects, could help prevent the severe complications of COVID-19, reducing the impact of the disease on individual patients and the demand on hospitals,” said
Scientific and Clinical Rationale for EDP1815 in COVID-19
The progression to severe COVID-19 is associated with cytokine storm and hyperinflammation. Based on data from a Phase 1b clinical trial in psoriasis, EDP1815 has the potential to modulate multiple immune pathways associated with cytokine storm and resolve the inflammation without the risks associated with immunosuppression.
In a Phase 1b clinical trial in psoriasis, EDP1815 limited the production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1b. It was well tolerated with no overall difference from placebo. In preclinical models, EDP1815 resolved inflammation across TH1, TH2, and TH17 pathways. This led to down-regulation of multiple cytokines 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.
EDP1815 is designed to harness the connections between intestinal mucosal immunology and systemic inflammation for broad inflammation resolution without immunosuppression. It is potentially unique amongst therapies currently being tested in COVID-19 patients for this mechanism of action, which, if approved, could result in a safe, effective, oral, and affordable product.
If EDP1815 is approved for the treatment of COVID-19, Evelo could rapidly scale its manufacturing to supply the drug at a reasonable cost. Additionally, if the COVID-19 trial is successful, the Company plans to investigate EDP1815 as a potential therapy for other diseases, such as influenza, in which cytokine storm and hyperinflammation play a role.
TACTIC-E is a platform Phase 2/3 trial in the
Update on EDP1815-205
In addition to the TACTIC-E trial, an Investigational New Drug (IND) application has been submitted for an Evelo-sponsored Phase 2 clinical trial, EDP1815-205, evaluating the safety and efficacy of EDP1815 for the treatment of hospitalised patients with newly diagnosed COVID-19 at
About Evelo Biosciences
Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases, and EDP1503 for the treatment of cancer. Evelo is advancing additional product candidates 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 without limitation statements concerning the development of EDP1815 for the treatment of patients with COVID-19, our development plans, the promise and potential impact of any of our monoclonal microbials or preclinical or clinical trial data, the timing of and plans for clinical studies of EDP1815, and the timing and results of any clinical studies or readouts, and the scalability of manufacturing for EDP1815.
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 completing clinical trials or in seeking or obtaining 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" Report on Form 10-Q for the quarter ended
Source: Evelo Biosciences, Inc.