Simple. High quality. Patient friendly.
That is how a unique rheumatoid arthritis (RA) drug, olokizumab, is being described by its supporters.
The investigational medication was officially presented at the annual European League Against Rheumatism (EULAR) meeting in London last week.
Dr. Charles Weaver, an oncologist and managing editor of theRAConnection, a leading social community and resource for RA patients, told Healthline the drug has performed well so far in its trials.
“The biologic therapy olokizumab continues to show promise as a novel treatment for patients with RA,” Weaver said.
A New Phase
The drug is being developed by R-Pharm, a Russian pharmaceutical and biotech startup that was founded in 2001 and specializes in high tech medical products.
The company launched a U.S. division in 2014.
Olokizumab is an IL-6 (interleukin-6) inhibitor that binds to the IL-6 cytokine in an effort to treat moderate to severe RA.
“Olokizumab is a humanized monoclonal antibody specific for the protein interleukin-6 cytokine (IL-6),” Weaver explained. “IL-6 plays a role in inflammation and can contribute to the signs and symptoms of RA by prompting white blood cells to attack certain tissues in the body.”
Dr. Peter Abaci, medical director at the Bay Area Pain and Wellness Center in Northern California, agrees.
"Blocking IL-6 is being looked at as a potential new form of treatment for RA, especially for cases resistant to tumor necrosis factor (TNF) inhibitors," he told Healthline. "Olokizumab, a novel IL-6 inhibitor, has shown promising results in phase 2 studies.”
R-Pharm announced last week that the U.S. Food and Drug Administration (FDA) gave approval for a phase III trial for olokizumab.
The drug has fared well in phase II studies. Outcomes showed that 12 weeks into treatment with olokizumab, patients had greater improvement than those who were given placebos.
These were patients who had previously failed anti-TNF treatment for their moderate-to-severe RA. (Anti-TNFs are a commonly prescribed class of RA drugs.)
According to an R-Pharm press release, Professor Patrick Durez from Université Catholique de Louvain, Brussels, Belgium, commented, “The findings from this new analysis confirm clinical improvement observed during the phase 2 clinical trials, which demonstrated efficacy and safety of olokizumab compared with placebo in adult RA patients who had previously failed treatment with TNF inhibitors.”
Olokizumab demonstrated enough improvements in patient-reported outcomes during the phase II study that it moved forward into the phase III trial. Olokizumab's phase III program was recently initiated, a few days before new data on the drug was presented at the EULAR conference.
In the company press release, Dr. Mikhail Samsonov, chief medical officer of R-Pharm said, “These are really positive results and build on previously reported clinical data as a basis for our recently initiated phase-3 program.”
RA treatments that are currently on the market often fail or lose efficacy over time, so any new drug on the horizon is a positive thing for patients who often fear they will run out of options for managing their disease.
For patients, what may be appealing about olokizumab is that the goal is “less drug but with greater effect.”
The dose is expected to be a subcutaneous injection that can be given every 2 or 4 weeks.
Having “patient friendly” treatments is a stated goal for the biotech company. Along with RA treatments, the company specializes in high tech drugs for other conditions including cancer and other immune and autoimmune diseases.
Olokizumab is a not a generic or a biosimilar. R-Pharm officials say they hope it will one day be available and affordable to RA patients around the world.
“As a patient, I like to have options. Any new drug that is in the works is an A-plus to me,” said Kathi Lewis of Pennsylvania. “Options and new research are lifelines and beacons of hope for those of us living with rheumatoid arthritis and chronic illness.”
Patients may have to be, well, patient while olokizumab goes through phase III clinical trials. It must show effectiveness in these more advanced trials before it is allowed on the market.