A RUSNANO Portfolio Company Has Completed Phase III Clinical Trials on the Drug Epolong to Help Treat Patients with Chronic Kidney Disease

09 December 2020

Pharmsynthez PJSC, which is a portfolio company for RUSNANO PJSC, successfully completed phase III clinical trials Epolong, an original drug designed to treat anemia in patients with chronic kidney disease (CKD).

The results of the Russian stage of the study, together with data collected from numerous phase I and II clinical trials in India, Australia, and New Zealand, validate that Epolong, when used twice a month with patients that have CKD, effectively restores hemoglobin levels while demonstrating a high safety profile. The next stage in the project to bring Epolong to the domestic pharmaceutical market will be obtaining a marketing authorisation. The registration phase is slated to be finished by the end of 2021.

In Russia, a multicenter, randomized study to study the efficacy, safety, and tolerability of Epolong (a conjugate of erythropoietin and polysialic acid) was done to compare it with Aranesp (darbepoetin alfa), which is a leader in the segment of long-acting erythropoietin medicines. One hundred fifty patients with CKD took part in the clinical trial in 36 healthcare facilities. The results of the study showed that Epolong is marked by a level of clinical efficacy no less than that of Aranesp. Along with that, the proportion of patients that reached the target hemoglobin level (ranging from 100-120 g/l inclusive) during the evaluation period for the treatment was 52% in the group that took Aranesp, and 74% in the group that took Epolong. The study also revealed that in the Epolong group the proportion of patients that exceeded the safe threshold level for hemoglobin (120 g/l) was 3.5 times less than in the Aranesp group (10.0% versus 34.7%). This may indicate that Epolong is safer in terms of the risk of developing cardiovascular complications.

“I am glad to announce that our company has successfully completed this stage in the clinical trials for Epolong,” stated Kirill Mayorov, the president of Pharmsynthez PJSC. “Today, the need for effective, safe, and long-acting erythropoietin medicines is becoming more acute against the backdrop of an increasing number of patients with CKD in our country, and the increases in the costs of treating them for the healthcare system. Our studies prove that Epolong can preserve the quality of life for patients, and reduce the risk of them developing concomitant cardiovascular complications. We will do our best to ensure that Russian doctors and patients get access to our formulation as soon as possible,” stated Kirill Mayorov.

Reference

Epolong is the first original Russian-produced drug that is a long-acting erythropoiesis stimulator. It was developed by Pharmsynthez PJSC in partnership with the Serum Institute of India, and the company Xenetic Biosciences, and incorporates polysialization technology (PolyXen).

It belongs to a new generation of drugs based on recombinant human erythropoietin, and has a number of undeniable advantages. The structure of Epolong is identical to erythropoietin, which is mostly produced by the kidneys in a healthy person; the drug does not require frequent injections, nor does it have any toxic effect due to its use of polysialic acid as the component that enables the duration of its action.

Additional information

Reference

RUSNANO Joint-Stock Company was founded in March 2011 through reorganization of state corporation Russian Corporation of Nanotechnologies. JSC RUSNANO contributes to implementation of the state policy on the development of the nanotechnology industry by investing directly and through investment funds of nanotechnology in financially effective high-technology projects providing the development of new production facilities in the Russian Federation. Its primary investment focus is in electronics, optoelectronics and telecommunications, healthcare and biotechnology, metallurgy and metalwork, energy, mechanical engineering and instrument making, construction and industrial materials, chemicals and petrochemicals. 100 percent of RUSNANO’s shares are state owned. Thanks to RUSNANO’s investments, there are currently 126 factories and R&D Centers opened in 38 regions in Russia.

Management of assets of RUSNANO JSC is carried out by Limited Liability Company established in December 2013, RUSNANO Management Company.

Work to establish nanotechnology infrastructure and carry out educational programs is fulfilled by RUSNANO’s Fund for Infrastructure and Educational Programs, which was also established during the reorganization of the Russian Corporation of Nanotechnologies.

* * *

Pharmsynthez PJSC (Saint Petersburg) is a public joint-stock company that develops and produces pharmaceutical substances and medicinal products, both as part of its own product range and under conditions that involve contract manufacturing. It has a unique production facility in Leningrad Region. Pharmsynthez PJSC is the parent company in a holding company whose key assets are Xenetic Biosciences (USA), the formulator of a range of promising medicinal products whose shares are traded on the NASDAQ stock exchange (ticker symbol XBIO), and Kevelt AS (Estonia), a GMP-certified developer and producer of medicines for the US, European, and CIS markets. Shares in Pharmsynthez PJSC are admitted for trading on the Moscow Exchange in the Innovation and Investment Market (IIM) section (ticker symbol LIFE). The RUSNANO Group is the majority shareholder in Pharmsynthez PJSC.

For more information about the company, visit en.pharmsynthez.com