and Cromos Pharma
today (28 April, 2020) 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.”
The trial is featured in Bioworld's In the Clinic update April 28.
Read more at Globenewswire
Find out more about R-Pharm here.