MOSCOW and PORTLAND, Ore., April 28, 2020 (GLOBE NEWSWIRE) -- R-Pharm JSC and Cromos Pharma today announced that it has randomized the first patients into a clinical trial evaluating Olokizumab and RPH-104 in patients with severe COVID-19 infection. Olokizumab (OKZ) is a humanized monoclonal antibody with high affinity for interleukin-6 (IL-6), and RPH-104 is a fusion protein that selectively binds and inactivates interleukin-1ß (IL-1ß). The overactive inflammatory response also called the “cytokine storm” has been implied to play a major role in progression of COVID-19 infection. By blocking the two most critical proinflammatory cytokines and thus inhibiting the inflammation cascade, OKZ and RPH-104 may suppress the development of Acute Respiratory Distress Syndrome (ARDS), the leading cause of death in patients with COVID-19.

The multi-center, double-blind, Phase 2/3 trial has an adaptive design that will have two components. Firstly, the trial will recruit around 180 patients with severe COVID-19 infection across approximately 20 hospital sites. Through 1:1:1 randomization it will evaluate efficacy and safety of OKZ, RPH-104 in addition to supportive care and supportive care alone in patients with severe COVID-19 infection. The results of the phase 2 part of the trial will be utilized in an adaptive manner to determine transition to the larger phase 3 part that will comprehensively assess the longer-term outcomes such as the need for mechanical ventilation and death.

“This trial is the first part of a global clinical program aimed at evaluating R-Pharm’s autoinflammatory medication pipeline to treat severe COVID-19 infection addressing critical unmet medical need,” said Mikhail Samsonov, MD, PhD, Chief Medical Officer of R-Pharm.

“We are honored to participate in this breakthrough clinical program that is aimed at determining if cytokine blockade with OKZ and RPH-104 can improve clinical outcomes in patients with COVID-19,” said Vlad Bogin, MD, FACP, CEO of Cromos Pharma. “The longer the pandemic continues the more critical it becomes to find effective treatments for this widespread and devastating disease.”

About R-Pharm

R-Pharm Group is one of the leaders of the Russian pharmaceutical market. It was founded in 2001 by Alexey Repik. In 2017, 10% of JSC R-Pharm’s shares were acquired by Japanese Corporation Mitsui & Co., Ltd. The mission of R-Pharm is to increase the accessibility of the most modern medicines for patients in Russia and all over the world. The company employs more than 3,000 highly qualified professionals who operate throughout the Russian Federation, CIS member states, USA, Germany, Japan and other countries. There are more than 70 branches and representative offices. R-Pharm’s headquarters are located in Moscow.

About Cromos™ Pharma

Cromos Pharma is an international CRO with expertise in delivering all aspects of clinical trials in all clinical phases and a range of therapeutic areas. Established in 2004, Cromos™ Pharma is a US-based company with strong regional presence in Central and Eastern Europe, Russia and Post-Soviet Bloc countries. The company provides a full spectrum of trial-related services which include clinical monitoring, regulatory approvals, medical writing, feasibility assessments and project management. Cromos™ Pharma, LLC is a privately-owned company.   

About Olokizumab (OKZ)

OKZ is a humanized antagonist mAb of the IgG4 isotype with high specificity for IL-6. It is being developed for the treatment of moderate to severe Rheumatoid Arthritis (RA).

OKZ potently neutralizes IL-6-mediated effects in vitro, and no evidence was found that OKZ could mediate activation of the IL-6 signaling pathway.

OKZ is currently being investigated in phase 3 clinical development for the treatment of rheumatoid arthritis (RA). Cumulatively, 2,720 subjects including 49 healthy volunteers have been exposed to OKZ in international interventional clinical trials to date. The phase 3 research program for patients with rheumatoid arthritis involves 2443 patients. The program includes international projects CREDO 1 (completed recently: 428 patients with RA, demonstrating that treatment with OKZ over a 24-week period was associated with significant improvements in the signs, symptoms and physical function of patients with RA, with a safety profile consistent with Phase 2 data for OKZ and with the data for approved agents of the same classIL-6 inhibitors class), the results of which were presented in 2019 at the American College of Rheumatology meeting. The results of CREDO 2 (CL04041023) and CREDO 3 (CL04041025), are expected in May-June 2020. An open label study CREDO 4 (CL04041024) is ongoing and includes patients who completed the first three studies.

About RPH-104

RPH-104 belongs to the class of targeted drugs acting on IL-1. It is a fusion protein that selectively binds and inactivates IL-1ß. RPH-104 is a small TRAP molecule, has a strong affinity for IL-1 with best in class tissue penetration and protein stability. Based on preclinical studies, the drug is being developed for use in humans for the treatment of diseases associated with increased activity of IL-1ß.

The safety of RPH-104 has been demonstrated in a phase I study of a single dose administration to healthy volunteers. To date, RPH-104 is undergoing phase 2 clinical trials in patients with gout (CL04018054) and idiopathic recurrent pericarditis (CL04018068) in the Russian Federation. In the US the drug has received an IND clearance for a trial in Schnitzler syndrome (CL04018066) and in the Russian Federation and Armenia to treat colchicine-resistant Mediterranean fever (CL04018065; C04018071). The Ministry of Health of the Russian Federation has recently approved a study in patients with acute myocardial infarction with ST-segment elevation (CL04018075).

Nicola Donnelly
Communications Director