23 July 2020

Filter for the "cytokine storm"

The technology of the company "Efferon" proved to be effective for the treatment of complications of coronavirus infection.

Sk.ru

Sorption columns for extracorporeal blood purification of the Skolkovo company "Efferon" were noted at a recent meeting of the head of the FMBA Veronika Skvortsova with residents of the Foundation. According to Ms. Skvortsova, the proposed technique "may be very much in demand for a wide range of tasks; in particular, there is potential for use in COVID-19 therapy, but this, of course, requires detailed study."

After Roszdravnadzor issued a permit for clinical use last year, the Efferon CT and Efferon LPS columns entered the Russian market and are exported abroad, he said Sk.ru Ivan Bessonov, co-founder of the company and Technical Director of Efferon: "The Federal Biomedical Agency has confirmed interest at the highest level to what we do," he says. – Very soon, in September, the return meeting in Skolkovo should take place. And on it we plan to report on the first results of joint work with the FMBA."

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The sorption column "Efferon CT" attracted attention at a meeting of representatives of Skolkovo with the leadership of the FMBA. Photo: Sk.ru .

The sorption column "Efferon LPS" is used for such life-threatening indications as sepsis and septic shock. Sepsis is caused by the strongest toxin, lipopolysaccharide (LPS). Which, in turn, explains why there are currently no medications that can effectively treat sepsis. The antibiotic solves the problem of the infection itself, but not the body's reaction to toxic LPS molecules. This was described in detail in an interview with Ivan Bessonov, which Sk.ru published in November 2019 . At the same time, the co-founder of Efferon noted that in the future the company would like to expand the range of possible applications of the solution developed by it.

At that moment, it was hard to imagine that this future would come in just a couple of months, with the beginning of the coronavirus pandemic.

Positive feedback system

"Last fall, when no one suspected the impending trouble, we were preparing for an outbreak of seasonal flu, which, even despite widespread vaccination, often proceeds with severe complications caused by the cytokine storm syndrome," recalls Ivan Bessonov. – This dangerous condition is often found in intensive care units and develops as a response to viral infections and other pathological processes. A year ago, the phrase "cytokine storm" was known only to specialists. Now almost everyone has found out about him."

Efferon CT columns contain a sorbent capable of selectively absorbing another type of therapeutic targets that differs from LPS molecules. We are talking about cytokine proteins, by producing which the body regulates the inflammatory response and fights infections.

Respiratory viral infections follow a similar scenario. They affect the epithelial cells of the lungs, which, in turn, begin to produce cytokines to fight infection. The latter contribute to the migration of immune system cells – macrophages and monocytes – to the area of tissue damage. They produce even more cytokines; there is a positive feedback, overproduction of cytokines and deregulation of the inflammatory response, which leads to damage to the walls of blood vessels and other internal organs. This is how the "cytokine storm" is arranged. The immediate threat to life is not only the virus itself, but also the immunity designed to fight it.

"So, in the fall we provided Efferon CT to infectious diseases hospitals in the hope that they would help patients with severe flu. In December, we received the first reports of the success of this approach, first from Moscow, from the ICB No. 2, then from Nizhny Novgorod. There, by the way, to our great surprise, among "our" patients there was infected with the "last" version of coronavirus SARS-2003. It became clear that our idea has prospects. Therefore, in the spring we met the new reality a little prepared."

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This is how the Efferon technology works. Photo: "Efferon".

At the end of March, Efferon entered into a strategic partnership agreement for the active introduction of sorption columns to the market with NANOLEK. This allowed us to step up deliveries. To date, Efferon LPS and Efferon CT columns are successfully used in a number of clinics in Moscow, St. Petersburg, Rostov-on-Don, Nizhny Novgorod, Surgut and other cities of the Russian Federation in the treatment of sepsis, bacterial viral pneumonia, acute respiratory distress syndrome (ARDS) and "cytokine storm".

At the same time, in March, scientific journals began publishing about the role and place of anti-cytokine hemosorption in the intensive care of a new coronavirus infection SARS-CoV-2. This approach is able to stop the contradaptive manifestations of the inflammatory response, this most important biological mechanism, without suppressing the work of the immune system completely, which looks very promising, I. Bessonov is sure.

It was soon shown that extracorporeal detoxification using Efferon CT columns really makes it possible to effectively reduce peak cytokine concentrations in the blood of patients with a new coronavirus infection.

From Kaliningrad to the Far East

The confidence of the co-founder of Efferon is based not only on clinical data. The latest version of the guidelines of the Ministry of Health of the Russian Federation ("Temporary guidelines: prevention, diagnosis and treatment of a new coronavirus infection") includes the method of anticytokine hemosorption. In this regard, Russia is not alone, we are talking about a global trend that began in China and continued in Europe, in particular, in Italy.

It is clear that qualitative research is difficult to conduct and publish while being in the epicenter of a pandemic, but doctors are currently summarizing the data and preparing publications on this topic. 

According to the interlocutor Sk.ru , the method is mainly used for intensive care patients with multiple organ failure syndrome: "The use of such therapy, as we see, allows us to slow down or expand its progression, increase such important therapeutic indicators as the oxygenation index, normalize blood pressure in patients with unstable hemodynamics. All this is confirmed by laboratory data – in particular, a decrease in the level of interleukin-6, the most important mediator of inflammatory processes in such patients; a decrease in the level of C-reactive protein."

Among the clinics that use the products of the company "Efferon", Ivan Bessonov calls the Moscow Center for Infectious Diseases in Voronovsky, which took one of the main blows of the pandemic. In Moscow, this is the State Security Bureau No. 40 in Kommunarka, the State Security Bureau No. 15 named after him. Filatov, State Library No. 1 named after Pirogov, State Library No. 68 named after Demikhov, NMIC of Obstetrics and Gynecology named after Kulakov, the Main Military Clinical Hospital named after Burdenko, Lomonosov Moscow State University; Botkin Hospital in St. Petersburg; dozens of clinics in the Urals, Siberia, Kaliningrad, Stavropol, and the Far East.

"The most important thing for us is that doctors come back with repeated orders, which means they see the effect of therapy and recognize its value," adds I. Bessonov.

Entering the international market

Meanwhile, Efferon is also entering the international market. Deliveries to Latin America are already underway. At the same time, the company is busy obtaining registration in Europe (CE mark), which will allow it to enter a variety of markets. In addition to Europe, Efferon is attracted to the Middle East, India, North Africa – in general, regions located in relative proximity to Russia.

Although we started, oddly enough, from the opposite end of the globe – Colombia. Here's the story here.

"Even before we were registered in Russia, we went, with the support of the Moscow Export Center, to exhibit in Germany at Medica, the largest exhibition on healthcare, and there was a very great interest in us from distributors from all over the world," says Ivan Bessonov. – But all of them need a CE mark to get started. Some of them did not wait for us, but themselves engaged in national registrations in their jurisdictions. Such quickness allowed them to take a good position in the market. Deliveries to Colombia are the direct result of such negotiations. National registration in Mexico is also being prepared now."

Latin America, along with the United States, is one of the most affected regions by the pandemic, and Colombia, where this week, according to CNN, the number of infected with coronavirus exceeded 200 thousand people, is among the six most affected countries in the Western Hemisphere. According to the co-founder of the company, now in the midst of the Covid-19 pandemic, Efferon CT columns are primarily in demand for export.

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