P-Pharm: Artserix (goflycept) previously RPH-104 (interleukin-1 inhibitor)

Main article: Cardiovascular diseases

2024

Obtaining the certificate "Made in Russia"

The first domestic original drug for the therapy of idiopathic recurrent pericarditis (IRD) Artserix (goflycept) received a certificate "Made in Russia" for export promotion under a national brand, which is sold by the Russian Export Center. The drug is marked in the categories "Reliability" and "Uniqueness." This was announced by R-Farm on December 3, 2024.

The main condition for obtaining a certificate "Made in Russia" - the company must produce products that have improved quality or improved characteristics. Successful verification of compliance with the program allows you to guarantee the reliability of the manufacturer and the safety of products when promoting abroad.

Artserix was developed from scratch in R-Pharm laboratories and is produced at the facilities of the group of companies. The drug is under patent protection in 59 countries around the world. As of December 2024, this is the only drug in Russia registered for pathogenetic therapy of IRD in patients over 18 years of age.

We are proud that fully domestic development already helps patients and sets standards in the treatment of such a serious disease as idiopathic pericarditis. Obtaining a certificate is not only a recognition of the high quality of the drug, but also an opportunity to expand access to advanced therapy for patients around the world, "said Vasily Ignatiev, General Director of R-Pharm.

Inclusion in VED list

The Commission of the Ministry of Health of the Russian Federation has expanded the list of vital and essential drugs (VED). It included a drug for pathogenetic therapy of idiopathic recurrent pericarditis in patients over 18 years old - Artserix (goflycept). This was announced by R-Farm on November 7, 2024.

The inclusion of goflycept in the VED list will allow patients to receive the drug under the programs of state guarantees of free medical care and the system of preferential drug provision.

Arcerix was developed by R-Pharm specialists and is a hybrid protein that binds proinflammatory cytokines of the IL-1 family and blocks their effect. The full production cycle of the drug has been established at the Yaroslavl plant of the group of companies.

This is an important step towards increasing the availability of effective treatments for patients with such severe and disabling diseases. hearts We are proud Russia that there are more and more domestic developments that strengthen the medicinal sovereignty of our country and create a solid foundation for sustainable development. pharmaceutical industries The inclusion of the drug in the list of vital drugs once again demonstrates a high level of confidence in Russian drugs, - said the Vasily Ignatiev general director of R-Pharm.

Designation of orphan medicinal product

The Ministry of Health of the Russian Federation has assigned Artserix (goflycept) the status of an orphan drug for the treatment of idiopathic recurrent pericarditis (IRD) in patients 18 years of age and older. This was announced by R-Farm on November 5, 2024.

The drug was developed from scratch in R-Pharm laboratories and is produced in Russia at the facilities of the group of companies. Artserix (goflycept) is under patent protection in 59 countries around the world.

Arcerix (goflycept) is a fusion protein, a heterodimer that binds and blocks the pro-inflammatory cytokines of the interleukin 1 family. The efficacy of goflycept in patients with IRD was confirmed in the COURSE study conducted in close collaboration FSBI "National Medical Research Center named after V.A. Almazova" Ministry of Health Russia with and a number of other cardiac centers.

Already on the third day after the first administration of goflycept, there was a decrease in the main symptoms of pericarditis, such as chest pain, C-reactive protein levels and pericardial effusion. In the clinical trial, no relapses of the disease were recorded in the group of patients taking goflycept.

We are confident that goflycept will significantly expand the capabilities of doctors in the fight against this disabling disease. Reducing the risk of relapse means patients will be able to live full lives. Understanding the medical need for IRD therapy in Russia, we make every effort to make it available. The Ministry of Health of the Russian Federation also notes the significance of the problem, providing the domestic drug with an orphan status, - said Vasily Ignatiev, General Director of R-Pharm.

"Artserix" registration

The R-Pharm Group has completed the registration of its own original product Artserix for the treatment of idiopathic recurrent pericarditis (IRD). The company announced this on June 17, 2024.

The drug was developed from scratch in R-Pharm laboratories and will be produced in Russia at the facilities of the group of companies. Artserix is under patent protection in 24 countries around the world.

Idiopathic recurrent pericarditis is an autoinflammatory disease that has orphan status in Russia. One of the leading mechanisms for the development of IRD is the excessive synthesis of proinflammatory cytokines of the IL-1 family (IL-1β and IL- 1α), which trigger a continuous circle of inflammation and lead to a recurrent course of the disease. Arcerix® (goflycept) is a new heterodimeric hybrid protein capable of binding with high affinity to human IL-1β and IL-1α.

The efficacy of goflycept in patients with idiopathic recurrent pericarditis was confirmed in the COURSE study conducted in Russia, in close cooperation FSBI "National Medical Research Center named after V.A. Almazova" Ministry of Health Russia with a number of other cardiac centers.

On the third day after the first administration of goflycept, there was a decrease in indicators of signs of recurrence (chest pain, C-reactive protein, pericardial effusion). No relapses were reported in the goflycept group during the study, as opposed to the placebo group, where relapse occurred in 90% of cases.

According to Russian and international experts, the results of the COURSE study suggest the need to change approaches to the therapy of idiopathic recurrent pericarditis.

{{quote 'The emergence in the country of the first original drug for the therapy of idiopathic recurrent pericarditis will significantly expand the capabilities of doctors in the fight against this disease. Reducing the risk of relapse means patients will be able to live full lives. Clinical studies of goflycept are ongoing. As of June 2024, its effectiveness and safety in family Mediterranean fever and other indications are assessed - the research program is deployed in Russia, Armenia and Turkey. We see that the drug has the potential for widespread commercialization in the world, "said Vasily Ignatiev, CEO of the R-Pharm group of companies. }}

Drug testing for familial Mediterranean fever in Turkey

The R-Farm Group, together with the Turkish company TRPharm, has launched international clinical studies of its own original drug goflycept for familial Mediterranean fever in Turkey. R-Pharm announced this on March 13, 2024.

The study, approved by the Ministry of Health of the Republic of Turkey, will be held on the basis of five centers. By mid-March 2024, the recruitment of patients continues in Turkey.

An international double-blind, placebo-controlled, randomized clinical trial of goflycept in patients with familial Mediterranean fever is taking place in several countries at once. In total, it is planned to recruit 60 patients into the program.

In Russia, the study takes place in five centers, including the E.M. Tareev Clinic of Rheumatology, Nephrology and Occupational Pathology of Sechenov University, the S.P. Botkin City Clinical Hospital and the FBUN Research Institute of Epidemiology and Microbiology named after Pasteur.

Familial Mediterranean fever is a rare genetic autoinflammatory disease that manifests itself with periodic fever, abdominal pain, chest pain, and joints. In the absence of treatment, patients may develop a severe complication - systemic AA-amyloidosis with damage to the kidneys and other organs. Goflycycept is an innovative protein drug that inactivates the cytokine interleukin- 1β (IL-1), which plays a major role in the development of Mediterranean fever. Previously, data were obtained on the efficacy and safety of goflycept in other IL-1-mediated diseases, including idiopathic recurrent pericarditis.

Familial Mediterranean fever is considered a rare disease, but in some regions its prevalence is quite high. For example, in Turkey, it is found in about 1 person out of 1000. Goflycycept has already proven its effectiveness in other autoinflammatory diseases, the results of its clinical trials were presented at major international conferences. The new study is taking place in Russia, Turkey and Armenia. We hope that soon we will be able to provide innovative treatment to patients in those countries where the disease is most common, "said Mikhail Samsonov, medical director of R-Pharm.

TRPharm supports initiatives related to raising awareness of rare diseases in Turkey. This contributes to the earlier diagnosis of such diseases and the timely - and more effective - treatment of them. In addition to Turkey, we are working to provide solutions for the treatment of rare diseases in the MENA region - in the Middle East and North Africa, said Ismet Inche, CEO of TRPharm.

2022: Phase II/III Clinical Trial Completed

On April 13, 2022, R-Pharm Group announced the completion of a phase II/III clinical trial of the original drug Artserix (goflycept) in patients with idiopathic recurrent pericarditis. The study took place on the territory of the Russian Federation, it is assumed that its results will become the basis for the registration of the drug in Russia in this orphan nosology.

Artserix (goflycept), formerly known as molecule RPH-104 is a biological drug developed in R-Pharm's own laboratory and is a heterodimeric protein that inhibits IL-1. The drug is being developed to treat a number of socially significant and orphan diseases characterized by systemic inflammation, including acute myocardial infarction, Schnitzler syndrome, COVID-19, recurrent pericarditis, family Mediterranean fever, gout, Still's disease.

As of April 2022, an international double-blind placebo-controlled study of the drug in patients with acute myocardial infarction with ST-segment elevation (IMpST) electrocardiogram is ongoing, in which more than 100 patients take part. In addition, the Ministry of Health of the Russian Federation received approval for the clinical study of Artserix in patients with another orphan pathology - Still's disease.

Earlier, the US Food and Drug Administration (US FDA) assigned the drug orphan status for the treatment of Schnitzler syndrome amid the absence of other drugs approved by the FDA for the treatment of this disease.

Knowledge of the pathogenesis of idiopathic recurrent pericarditis and data from recent studies demonstrate that interleukin-1 blockade can be considered as a leading mechanism for achieving remission. We are convinced that registration of the original development of R-Pharm will be the most important step towards the victory of global medicine over this dangerous disease, "said Mikhail Samsonov, medical director of R-Pharm.

2021: International Study of First Patients

On 21 Jan 2021, R-Pharm reported the inclusion of the first patients in the international double-blind placebo-controlled study of RPH-104 (interleukin-1 inhibitor) in patients with ST-segment elevation acute myocardial infarction (IMpST) electrocardiogram. In total, 102 patients will be included in the study in Russia and the USA. Patients with acute MIpST will receive a single subcutaneous injection and then be monitored by a cardiologist for a year to assess the efficacy of the drug on systemic inflammation and disease outcomes.

Acute myocardial infarction is a common form of coronary heart disease characterized by high mortality. Interleukin-1 plays an important role in the development of an inflammatory response after infarction and is involved in the process of myocardial remodeling. An inflammatory reaction exacerbates heart damage and is a predictor of an increased risk of death or developing heart failure. We believe that suppressing IL-1 by RPH-104 may lead to minimizing the effects of disease in patients with MIpST. said Mikhail Samsonov, Director of the Medical Department of R-Pharm

RPH-104 is a biological preparation developed in the laboratory of R-Pharm in the USA, which is a heterodimeric protein that inhibits IL-1. The drug is being developed to treat a number of socially significant and orphan diseases characterized by systemic inflammation, including acute myocardial infarction, Schnitzler syndrome, COVID-19, recurrent pericarditis, family Mediterranean fever, gout. The U.S. Food and Drug Administration (US FDA) has granted the drug RPH-104 orphan status for the treatment of Schnitzler syndrome. As of January 2021, no drug products approved by the FDA for the treatment of Schnitzler syndrome exist.

ST-segment elevation myocardial infarction (STEMI) is a clinical syndrome of acute ischemia and myocardial necrosis associated with a high risk of hospital and long-term morbidity and mortality. According to to data the European the register, mortality among patients with MIpST after 6 months can exceed 12%, during the first year it is about 10% and can reach 20% within 5 years.