Evelo Biosciences has announced the inclusion of its experimental drug candidate, EDP1815, in the Phase II/III TACTIC-E clinical trial being conducted in the UK.
The trial is intended to assess the safety and efficacy of some investigational therapies for preventing and treating complications caused by Covid-19 in hospitalised patients at the early stages of the infection.
TACTIC-E is led by Dr Joseph Cheriyan from Addenbrooke’s Hospital in Cambridge, UK, with Cambridge University Hospitals NHS Foundation Trust sponsoring the study.
According to results from a Phase Ib trial in psoriasis patients, EDP1815 could regulate different immune pathways related to cytokine storm and resolve the inflammation without immunosuppression.
TACTIC-E will enrol up to 469 patients per arm at multiple clinical centres across the UK.
The trial will recruit patients with identified risk factors for developing severe complications and who are at risk of progression to the intensive care unit or death.
Participants will be given EDP1815 or a ambrisentan and dapagliflozin combination, with standard of care, or standard of care alone.
The primary outcome measure is a decrease in the number of patients developing severe complications of organ failure, ventilation or death, while secondary outcomes include duration of hospital stay and oxygen therapy, changes in Covid-19 progression biomarkers, and time to clinical improvement.
Interim results are expected to be available during the fourth quarter of this year. If positive data is obtained, Evelo plans to hold discussions with regulatory agencies for potential registration.
Evelo Biosciences chief scientific officer Mark Bodmer said: “EDP1815 has the potential to address the complex inflammatory chaos associated with cytokine storm in Covid-19 without immunosuppression.
“EDP1815’s mechanism of action may make it suitable for early intervention in Covid-19 patients who have not yet been shown to benefit from anti-inflammatory therapy.”
If the drug candidate secures approval to treat Covid-19, Evelo can rapidly scale its manufacturing and provide it at an affordable cost.