The TACTIC-E trial will investigate the safety and efficacy of experimental therapies designed to prevent and treat life-threatening complications associated with COVID-19 in hospitalized patients who are at early stages of the disease.
Shares of Evelo Biosciences were up more than 25% in premarket trading after the company announced its investigational asset EDP1815 will be included in the Phase II/III TACTIC-E COVID-19-focused clinical trial for conducted by Cambridge University Hospitals NHS Foundation Trust.
The TACTIC-E trial will investigate the safety and efficacy of experimental therapies designed to prevent and treat life-threatening complications associated with COVID-19 in hospitalized patients who are at early stages of the disease. The study will enroll COVID-19 patients who have identified risk factors that could lead to their developing severe complications, which put them at risk of being placed in an intensive care unit or lead to death. There is a strong focus on modulating the immune response, given that progression to severe COVID-19 is associated with hyperinflammation and cytokine storm. Evelo’s EDP1815 was selected for this study following data from a Phase Ib psoriasis study that showed the medication has the ability to modulate multiple inflammatory pathways.
In a Phase Ib 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 also resolved inflammation across TH1, TH2, and TH17 pathways, Evelo noted. EDP1815 acts on cells in the lining of the small intestine and triggers signals which act throughout the body, even though the investigational drug has not been observed to leave the gut or circulate around the body, Evelo added.
Joseph Cheriyan, Consultant Clinical Pharmacologist at Addenbrooke’s Hospital in Cambridge England and the lead investigator of the TACTIC-E study, said EDP1815 was selected for the trial given the tolerability and the modulation of multiple inflammatory pathways observed in that Phase Ib study.
Mark Bodmber, Evelo’s chief scientific officer, said the recent results from a study of the steroid dexamethasone suggest that an oral treatment like EDP1815, which has potential broad anti-inflammatory effects, could prevent severe complications by COVID-19. The U.K. study regarding dexamethasone showed the drug only demonstrated efficacy in 30% of critically ill patients.
“EDP1815 has the potential to address the complex inflammatory chaos associated with cytokine storm in COVID-19 without immunosuppression. In a prior clinical trial in psoriasis, EDP1815 was well tolerated with no overall difference in safety findings from placebo. 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 EDP1815 is successfully developed and approved, it can be manufactured at scale and at an affordable cost, which could potentially address a large patient population,” Bodmer said in a statement.
If EDP1815 demonstrates efficacy in COVID-19 patients in the TACTIC-E study, Evelo said it plans to work with regulatory agencies to determine if the data support registration. Interim data from the TACTIC-E study is expected in the fourth quarter of 2020.
