ExeGi Pharma LLC, a U.S.-based company focused on developing and commercializing products targeting the human microbiome, including live biotherapeutic products (LBPs), announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in the peer-reviewed journal Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy.
As the COVID-19 crisis exploded in Italy and clinicians struggled to navigate patient care, investigators at Policlinico Umberto I, “Sapienza” University of Rome hypothesized that a bacterial formulation, with a specific biochemical and immunological profile, could trigger the production of antiviral molecules and potentially mitigate COVID-19 severity via modulation of the gut-lung axis.
To explore the question, investigators enrolled a group of 70 patients with COVID-19 who had a fever, demonstrated greater than 50 percent lung involvement on computerized tomography imaging, and required non-invasive oxygen therapy (non-intubated patients). The 42 patients in the first study group received the standard treatment of hydroxchloroquine, antibiotics, and tocilizumab. The 28 patients in the second study group received standard treatment, plus a high-dose, eight-strain bacteriotherapy.
Of the patients in the bacteriotherapy group, all experienced an elimination of diarrhea within seven days, while fewer than half of the patients who were not treated with bacteriotherapy had a disappearance in diarrhea. The bacteriotherapy group also showed significant improvements in other signs and symptoms associated with COVID-19, including fever, shortness of breath, abnormal physical weakness, and myalgia.
Additionally, two patients not treated with bacteriotherapy were transferred to the intensive care unit for mechanical ventilation compared to none in the bacteriotherapy group (4.8 percent vs. zero) and four patients in the control group died as a result of the disease compared to none in the treated group (9.5 percent vs. zero), though these results were not statistically significant. No adverse events were recorded in the bacteriotherapy group.
In short, all patients treated with standard therapy plus bacteriotherapy survived the COVID-19 illness, and none required invasive mechanical ventilation or ICU admission.
“While this data comes from a small study via a retrospective real-life emergency data collection, it highlights gut/lung axis seen in existing research and suggest a potential role for bacteriotherapy in the management of COVID-19 for seriously ill patients,”
said Giancarlo Ceccarelli M.D., Ph.D., one of the study investigators.
“The urgency of identifying useful clinical tools to navigate the pandemic and these encouraging initial results make additional clinical evaluation of this formulation a high priority for our team.”
“From the start of the COVID-19 crisis, researchers have considered a possible link between the gut microbiome and disease progression and, while this formulation is investigational, the data point to a potential new tool for clinicians treating patients with the disease,”
said ExeGi Pharma CEO Marc Tewey.
“We look forward to further clinical evaluation of this formulation by the investigators and plan to work with the FDA to identify the appropriate pathway for U.S. regulatory review.”