Evelo Biosciences, along with Rutgers University and Robert Wood Johnson University Hospital, is driving toward a Phase II study of an investigational treatment for hospitalized patients with newly diagnosed COVID-19.
Evelo Biosciences, along with Rutgers University and Robert Wood Johnson University Hospital, is driving toward a Phase II study of an investigational treatment for hospitalized patients with newly diagnosed COVID-19.
The company is aiming a drug initially under development for psoriasis at COVID-19 based on early clinical data that shows its efficacy in blunting the production of multiple inflammatory cytokines – the same kind that many serious COVID-19 patients are dealing with. The progression to severe COVID-19 is associated with hyperinflammation, including cytokine storm. In a Phase Ib trial in psoriasis, Evelo’s EDP1815 demonstrated favorable tolerability and anti-inflammatory activity in a prior clinical trial. The trial showed marked activity on multiple individual systemic markers of inflammation, including interleukin-6 (IL-6) and interleukin-8 (IL-8), as well as TNF, and IL-1b, Evelo announced in March. Based on data from the Ib study, Evelo believes that EDP1815 has the potential to modulate multiple immune pathways associated with cytokine storm to resolve inflammation without causing complete immunosuppression.
Treatments for newly-diagnosed patients are being sought after by multiple companies and organizations in order to prevent the progression of the disease to more serious stages. These treatments will also become more essential as governments begin to look at reopening economies that have been largely shuttered due to the COVID-19 pandemic. News of the Phase II trial sent shares of Evelo Biosciences climbing in premarket trading. The stock is up more than 34% to $6.46 after closing Wednesday at $4.79 per share.
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). 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 Phase II study is expected during the second half of this year.
“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,” Mark Bodmer, chief scientific officer at Evelo said in a statement. “If we see positive data from this Phase II study, we plan to move rapidly into Phase III, with the goal of advancing EDP1815 towards potential registration.”
If EDP1815 is approved for COVID-19, Evelo said it could rapidly scale its manufacturing to supply the drug at a reasonable cost.
The Rutgers Institute for Translational Medicine and Science and the New Jersey Alliance for Clinical and Translational Science (NJ ACTS) will conduct the study. It will be led by Dr. Reynold A. Panettieri, vice chancellor for Translational Medicine and Science at Rutgers Biomedical and Health Sciences and Professor of Medicine at Rutgers Robert Wood Johnson Medical School.
“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,” Panettieri said in a statement.
If this Phase II is successful in COVID-19, Evelo said it plans to investigate EDP1815 as a potential therapy for other diseases such as influenza in which hyperinflammation and cytokine storm play a key role.
