Evelo Biosciences, Rutgers University, and Robert Wood Johnson University Hospital (RWJ) announced the submission of an Investigational New Drug (IND) application for an Evelo-sponsored Phase 2 clinical study evaluating the safety and efficacy of EDP1815 for the treatment of hospitalized patients with newly diagnosed COVID-19. The study will be led by Reynold A. Panettieri, Jr., M.D., Vice Chancellor for Translational Medicine and Science at Rutgers Biomedical and Health Sciences and Professor of Medicine at Rutgers Robert Wood Johnson Medical School.
“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 Dr. Panettieri. “Our infrastructure at Robert Wood Johnson University Hospital allows us to detect COVID-19 rapidly in patients as they present in the emergency room. Given the tolerability and the modulation of multiple inflammatory cytokines observed in a Phase 1b clinical study of EDP1815, I believe this oral investigational drug may offer benefits to patients at risk of developing severe complications related to COVID-19. We look forward to evaluating EDP1815 in this important trial.”
The Rutgers Institute for Translational Medicine and Science and the New Jersey Alliance for Clinical and Translational Science (NJ ACTS) will conduct the study. EDP1815-205 is a Phase 2 double-blind placebo-controlled study investigating the safety and efficacy of oral EDP1815 in the treatment of hospitalized patients with newly diagnosed COVID-19, age 15 and older. The study will initially evaluate 60 patients to determine whether early intervention with EDP1815 can prevent progression of COVID-19 symptoms and the development of COVID-Related Complications (CRC). Eligible participants will be dosed with EDP1815 or placebo, on top of standard of care, for 14 days. They must have presented at the emergency room within the last 36 hours and tested positive for COVID-19. The primary endpoint is reduced requirements for oxygen therapy, measured by the ratio of oxygen saturation (SpO2) / fraction of inspired oxygen (FiO2). Secondary endpoints include symptom duration, progression along the WHO scale of disease severity, and mortality. Data from the study are expected during the second half of 2020.
“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 Mark Bodmer, Ph.D., chief scientific officer at Evelo. “If we see positive data from this Phase 2 study, we plan to move rapidly into Phase 3, with the goal of advancing EDP1815 towards potential registration.”
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.
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