electroCore (ECOR) Announces Top Line Results from SAVIOR-1 study of Non-Invasive Vagus Nerve Stimulation (nVNS) in Hospitalized COVID-19 Patients

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the top-line results from the SAVIOR-1 study, a prospective, randomized, controlled study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore Sapphire in patients admitted to the hospital for treatment of COVID-19 between April 2020 and February 2021. This study was an investigator-initiated trial conducted at the Hospital Clínico Universitario de Valencia, Spain.

The SAVIOR-1 study enrolled 110 patients over 18 years of age. A total of 97 patients (47 treatment subjects and 50 control subjects) provided baseline demographic and medical history data. The study was designed to evaluate the safety and feasibility of nVNS in addition to the current standard of care in patients hospitalized with active SARS-CoV-2 infection. This pilot study also assessed the incidence of relevant clinical events and changes in blood chemistry between the group treated with nVNS in addition to the standard of care at the time of admission, compared with standard of care alone.

The patients’ clinical and biochemical endpoints were measured over their first five days of therapy and the adjusted means were compared. It was noted that the post-randomized assessment of severity of condition resulted in a 3.5 to 1 bias with more severe patients in the treatment arm. With respect to the clinical endpoint of oxygen saturation, the nVNS treated group showed a modest, but not significant improvement. Among the biomarkers evaluated, the adjusted mean decrease in C-Reactive Protein (CRP) from baseline was significantly greater in the nVNS treated group (-59.08 vs. -27.83; p<0.01). Trends toward significance were also observed for decreases in the treatment group for procalcitonin (-0.11 vs. -0.05; p= 0.07) and d-dimer (-277.53 vs. 1264.37; p=0.08). Increased levels of CRP, procalcitonin and d-dimer have all been reported to be associated with more severe disease. The lower levels of these markers in the nVNS treated group may represent the initial impact of nVNS therapy to potentially improve the course of a patients’ COVID-19 symptoms. Other biochemical measures also favored the treatment group but did not achieve significance.

nVNS was well tolerated with no major device related adverse events and the therapy was administered three times daily on the majority of patients as outlined in the study protocol. Full data from the study, including cytokine levels which are pending final lab results, will be submitted to a peer reviewed journal later this year.

The principal investigator of the study, Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de Valencia, Spain, commented, "We are very pleased to have successfully completed the SAVIOR-1 study despite the challenges of executing a trial of a novel neuromodulation treatment during a pandemic, and the rapidly changing standard of care in COVID-19 patients. These top line results suggest that nVNS may contribute to our efforts in combating the on-going disease process through a more rapid recovery in some of the biomarkers that are typically associated with a more severe prognosis.”

"The ability of nVNS to potentially affect the progression of COVID-19 in these hospitalized patients is encouraging.” said Dr. Peter Staats, Chief Medical Officer of electroCore. “As the pandemic evolves, we believe that nVNS could be a viable treatment for patients to possibly help decrease their symptoms early in the disease. Although a minority of the subjects in the study were classified as severe, the randomization process apportioned more than 75% of the severe population into the treatment arm, which may have impacted the top line results.”

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