Nanolek and Efferon announce the launch of a strategic partnership for taking active efforts to market a specialized medical device that can also be used in treatment of acute respiratory infections caused by SARS-CoV-2 (COVID-19).

Efferon, which is a resident of the Science Park of Moscow State University and the Skolkovo Foundation Biomedical Cluster, has developed and is now producing two new medical devices for extracorporeal therapy – Efferon CT absorption columns to relieve cytokine storm syndrome and treat acute respiratory distress syndrome (ARDS), and Efferon LPS for the treatment of sepsis and septic shock, whose most common pathogenetic causes are bacterial lipopolysaccharides. Both medical devices received market authorization granted by Roszdravnadzor and are approved for use in clinical practice.

“It is known that SARS-CoV-2 causes atypical pneumonia (COVID-19) which is accompanied by life-threatening complications: firstly, acute respiratory distress syndrome (ARDS) and secondly, sepsis that can develop in a weakened body during a difficult treatment process, including with the use of ventilators. The experience of physicians from Wuhan, the epicenter of the new epidemic, shows that extracorporeal blood purification can stop the progression of such complications.

The blood of a patient is pumped under low pressure through a plastic cylindrical column filled with a special absorbent polymer. The surface of the absorbent selectively binds the spectrum of therapeutic targets. The purified blood flows back to the circulatory system, and the toxic substances firmly bound to the absorbent are removed from the body and disposed of. In recent years, extracorporeal blood purification has been widely and successfully used in treatment of critical conditions, and has recently been included in the Chinese recommendations for the treatment of atypical pneumonia in patients with SARS-Cov disease,” explained Ivan Bessonov, Co-Founder and Technical Director of Efferon.

The Efferon LPS and Efferon CT columns are currently successfully used in a number of clinics in Moscow, St. Petersburg, Rostov-on-Don, Nizhny Novgorod, Surgut and other cities across the Russian Federation in the treatment of sepsis, bacterial-viral pneumonia, acute respiratory distress syndrome (ARDS) and the cytokine storm.

V.B. Chentsov, Head of the Anesthesiology and Resuscitation Department, IDH (infection disease hospital) No. 2, Candidate of Medical Sciences, Senior Anesthesiologist and Resuscitationist:

“When using the Efferon CT column in a patient with acute respiratory distress syndrome, which developed as a result of viral pneumonia caused by AH1N1 flu, we saw a distinct improvement of health condition. Oxygenation increased rapidly (for example, from 86% when using pure oxygen to 100% with oxygen mixture).”

The Efferon LPS column is also used in treatment of sepsis.

N.D. Ushakova, Anesthesiologist and Resuscitationist, Department of Anesthesiology and Resuscitation, Rostov Research Center for Oncology, MD, professor, MD:

“When performing surgery in a patient with lung cancer suffering from lung destruction, absessed paracancerous pneumonia, one of abscess areas was drained and pus entered the pleural and pericardial cavities . Since the patient was in an extremely critical condition (mechanical ventilation, vasopressor support) and developed an acute lung damage based on clinical laboratory and X-ray findings and didn’t show positive response to treatment, a hemoperfusion using the Efferon LPS column was made a day after the operation along with intensive care.

As early as two hours after the completion of the procedure, the hemodynamics were stabilized, interleukin-6 in blood decreased significantly, vasopressor support was waived. On the third day of the postoperative period after complete recovery of consciousness and muscle tone, the patient was treated with non-invasive ventilation. On the fifth day the patient was transferred to a specialized department for further treatment. This is an illustrative clinical example showing the possibility to prevent the development of acute lung damage in surgically wounded patients following radical thoracoscopic surgery”.

According to the WHO, for every 100,000 people, about 200 cases of blood poisoning (sepsis) are recorded and this figure is growing annually. Throughout the world, sepsis is also one of the leading causes of death in medical institutions: from 30% to 60% of cases of this disease result in the death of the patient.

“Right now, the partnership between Nanolek and Efferon is becoming even more important, since the method of selective hemosorption has proven to be effective in countries such as Italy, China, Panama, and others. We hope to use it on a regular basis in treatment of pneumonia caused by SARS-CoV-2, and in our country. One of the worst consequences of this virus is acute respiratory distress syndrome (ARDS). According to the Russian Ministry of Health, excessive response of the immune system with a rapidly developing fatal cytokine storm play a major role in the pathogenesis of ARDS caused by SARS-CoV-2 infection. Studies have shown that mortality with COVID-19 is also associated with increased levels of interleukin-6 (IL-6).

The principle of the Efferon CT column is to bind any excess of tissue-damaging cytokines, such as IL-6 and IL-8, etc. The use of such a hemosorption column lowers mortality of patients and the length of time spent in intensive care, and reduces the need for ventilators which are so desperately required today. This is especially important since almost half of patients with severe lung damage from coronavirus are people under 60 years of age, making up 45% of the total number of patients in a severe condition according to Interfax. 15% of patients in a severe condition are under the age of 40,” says Vadim Kalinichenko, Head of the Nanolek Medical Department.

“We need a strong partner – a Russian company that has extensive experience in launching drugs with various applications to market. We are pleased that we and Nanolek have similar history and share common principles of doing business. Our colleagues from Nanolek created a start-up and are fully aware of challenges in the fleding period. We colloborate with each other easily and comfortably as we share a common language and have a common goal, which is to provide people with access to the best global technologies. We are confident that with the team of Nanolek will help us expand the range of applications of our device and make it available for patients in Russia,” says Ivan Bessonov.

About EFFERON

Efferon was established in 2017 by graduates of the Department of Chemistry of Lomonosov Moscow State University and INEOS RAS (Nesmeyanov Institute of Organoelement Compounds of the Russian Academy of Sciences). The company is a resident of the Science Park of Moscow State University and the Skolkovo Foundation Biomedical Cluster. It has developed and is now producing two new medical devices - Efferon CT absorption columns for the treatment of cytokine storm syndrome and acute respiratory distress syndrome (ARDS), and Efferon LPS for the treatment of sepsis and septic shock. Both medical devices received market authorization granted by Roszdravnadzor and are approved for use in clinical practice. The columns have been successfully tested at the Medical Scientific and Educational Center of Lomonosov Moscow State University, City Clinical Hospital No. 67 named after L.A. Vorokhobov, City Clinical Hospital No. 1 named after N.I. Pirogov, Infectious Diseases Hospital No. 2, National Medical Research Center of Oncology (Rostov-on-Don) and many other advanced medical institutions.

About NANOLEK

Nanolek is a modern, fast-growing Russian biopharmaceutical company with its own high-tech full-cycle production facility that meets GMP standards, specializing in the production of innovative and generic drugs, developed both by the company and in collaboration with international partners, with a focus on the prevention and treatment of socially significant diseases. Today, the company is one of the leading producers of pediatric vaccines in Russia. NANOLEK’s diversified medicinal product portfolio features following areas: vaccines, drugs for treatment of HIV, cance, etc. The company has unique experience in the transfer of technologys in collaboration with leading global pharmaceutical companies.