Data from a newly published case series underscores the effectiveness of Cytosorbents Corp.’s blood purification technology in treating critically ill COVID-19 patients. Notably, the retrospective review of patients who received Cytosorb treatments showed a 28-day survival rate post-admission to an intensive care unit (ICU) of 70%.

The report by Abdularahman Alharthy and colleagues on the use of Cytosorb in 50 critically ill COVID-19 patients who required renal replacement therapy for acute kidney injury represents the largest published case series to date on Cytosorb in this population. Patients averaged 49.6 years on ICU admission, with a scored mortality risk of greater than 40%. All of the patients were hyperinflamed with multiple organ failure, requiring life-saving interventions such as mechanical ventilation, renal replacement therapy or vasopressor drugs. Nearly one-fourth of patients had blood clots in their lungs.

According to the report, patients received continuous Cytosorb treatment plus continuous renal replacement therapy (CRRT), replacing the Cytosorb cartridge every 24 hours, until they achieved normal oxygenation, elimination of shock without vasopressors and absence of electrolyte and metabolic abnormalities. Patients also received standard of care therapies such as antibiotics, steroids and low tidal volume ventilation.

Among the 70% of patients who survived, all were successfully weaned from mechanical ventilation and vasopressors and discharged to their home by 32 days ± 12 days after ICU admission. Nonsurvivors had greater blood clot burden and more advanced thromboembolic disease at the time of ICU admission. The fact that cytokine reduction does not break down clots could explain those patients’ lack of response to Cytosorb therapy, the researchers said.

The case series was published Nov. 15, 2020, in the journal Artificial Organs.

Compares favorably to major dexamethasone study

Philip Chan, Cytosorbents’ CEO, called the findings timely, given the recent worldwide upsurge in new COVID-19 infections.

The 70% survival rate “compares favorably to an expected survival of less than 60% … and probably less than 50% … based on the APACHE 2 score that assesses severity of illness,” Chan told BioWorld via email. “This is the same survival percentage as seen in the much publicized U.K. RECOVERY trial with the use of dexamethasone in a patient population that had less severe disease with mainly isolated lung failure on mechanical ventilation.”

In both studies, the mortality rate was about 30%. But unlike the RECOVERY patients who only had lung failure, the Alharthy study included patients with acute kidney injury requiring CRRT, as well as septic shock. Given the increased odds of death in the Alharthy group, the results suggest Cytosorb has an additive benefit, he said.

The lack of benefit in nonresponders also yielded insights. “Blood clots in blood vessels throughout the body are now known to play a major role in the pathophysiology of the disease, including the severe lung failure that patients develop,” Chan said. “Once patients get to this stage, it is less likely that Cytosorb can help as cytokine storm reduction will not dissolve blood clots. So the results imply that earlier intervention with anticoagulation and Cytosorb may be the more effective approach.”

EUA, breakthrough designation

Monmouth, N.J.-based Cytosorbents received emergency use authorization from the U.S. FDA in April to use Cytosorb in patients with COVID-19 infection. To date, it has been used in over 2,800 coronavirus patients in more than 30 countries, including at many U.S. hospitals.

CE-marked since 2011, the device scored an expanded approval last spring for the removal of rivaroxaban (Zarelto) during cardiothoracic surgery requiring cardiopulmonary bypass. It is currently distributed in 66 countries and has been used in more than 110,000 treatments.

In the U.S., the Cytosorb has won FDA breakthrough status for the removal of the blood-thinning drug tricagrelor (Brilinta) during cardiothoracic surgery. “We met recently with the FDA and expect to have a direction on regulatory path soon, potentially in the next month or so,” Chan said.

He added that the company is continuing to enroll patients in the U.S.-based Cytosorb Therapy in COVID-19 ICU Patients (CTC) Registry and should complete an interim analysis by the end of the year.

Based on results by Alharthy et al., Cowen analyst Joshua Jennings reiterated an “Outperform” rating, with a $14 price target. In addition to the breakthrough designation, “by year-end, we should receive the top-line results of the Remove trial of Cytosorb in endocarditis,” he wrote in a Wednesday note. “We believe Cytosorb will remain a potential solution for endocarditis under multiple different outcome scenarios for Remove, so we see the trial results as a likely near-term catalyst for the stock.”