Type: Monoclonal microbial, a single strain of microbes selected for defined pharmacological properties. EDP1815 is being developed for the treatment of inflammatory diseases.
2021 Status: Evelo Biosciences joined Abdul Latif Jameel Health on March 23 to announce they entered into a strategic collaboration to develop and commercialize EDP1815 in the Middle East, Turkey, and Africa. Abdul Latif Jameel Health focuses on addressing unmet medical needs in developing markets as a unit of Abdul Latif Jameel, a global investor and diversified business operating in some 30 markets across six continents, with most of its operations in the Middle East, Turkey, and North Africa.
Evelo said received an upfront payment and equity investment, both undisclosed. Evelo agreed to oversee the development and manufacturing of EDP1815, whilst Abdul Latif Jameel Health agreed to oversee regulatory submissions and commercialization activities in the agreed-upon regions. Evelo and Abdul Latif Jameel Health will participate in a 50:50 profit share arrangement.
2020 Status: Evelo, Rutgers, and Robert Wood Johnson University Hospital said May 7 they submitted an IND application to the FDA for an Evelo-sponsored Phase II clinical study evaluating the safety and efficacy of EDP1815 for the treatment of hospitalized patients with newly diagnosed COVID-19.
The double-blind placebo-controlled study, EDP1815-205, 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. 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, Evelo said.
The primary endpoint is reduced requirements for oxygen therapy, measured by the ratio of oxygen saturation (SpO2) / fraction of inspired oxygen (FiO2). Data from the study are expected during the second half of 2020.
Evelo cited the tolerability and the modulation of multiple inflammatory cytokines observed in a Phase Ib clinical study assessing EDP1815 in psoriasis. In that study, EDP1815 was seen 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, Evelo said, 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.
The study’s principal investigator is Reynold A. Panettieri, Jr., MD, Vice Chancellor for Translational Medicine and Science at Rutgers Biomedical and Health Sciences and Professor of Medicine at Rutgers Robert Wood Johnson Medical School.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: