R-Pharm recently reported positive results from Phase 2 clinical trials of olokizumab for the treatment of rheumatoid arthritis, supporting the drug’s move into Phase 3 testing now underway. The data was presented at the 2016 ACR/ARHP Annual Meeting in Washington, D.C.
Olokizumab is an antibody against the inflammatory factor IL-6, which is involved in mediating autoimmune processes in rheumatoid arthritis. R-Pharm obtained the license for olokizumab from UCB in 2013.
Two Phase 2 trials assessing olokizumab (NCT01242488 and NCT01463059) enrolled rheumatoid arthritis patients, with moderate to severe disease, who did not respond to treatment with TNF blockers. The presentations also included data on two open-label extensions of the Phase 2 trials (NCT01296711 and NCT01533714, respectively).
The studies showed that both Western and Asian patients receiving olokizumab reported better outcomes at week 12 than those receiving placebo. The improvements held up to week 48 in the extension studies.
Placebo group patients who switched to olokizumab in the extension studies also benefited from the treatment, and had similar improvements in physical function, pain, fatigue, health status, and rheumatoid arthritis symptoms.
“These results for olokizumab show improvement for a wide range of patients in key patient reported outcomes such as physical function, pain, and fatigue, and are very encouraging to support the further development of olokizumab in RA [rheumatoid arthritis],” Mark Genovese, a professor at Stanford University and principal investigator for the clinical trials program, said in a press release provided by R-Pharm to Rheumatoid Arthritis News.
In addition to patient outcomes, R-Pharm also presented data from a dose-modeling study to determine the optimal dose for Phase 3 trials.
Researchers used information from the initial Phase 2 studies to find the optimal trade-off between effectiveness and safety. R-Pharm stated that dose modeling is a useful tool, allowing the combination of data from smaller studies, not designed to reveal differences in outcomes between doses.
“We are delighted with these results and committed to quickly developing olokizumab, as physicians and patients seek a more flexible and cost-effective option for managing RA,” said Mikhail Samsonov, chief medical officer of R-Pharm.
R-Pharm has launched a large-scale olokizumab Phase 3 trial program, assessing the safety and efficacy of olokizumab in patients who are not helped by methotrexate or TNF blocking drugs. The program is made up of three trials: CREDO 1 (NCT02760368) that will run in Russia, Belarus, Bulgaria, and Turkey, and the two global studies CREDO 2 (NCT02760407), and CREDO 3 (NCT02760433).
CREDO 4 is a planned open-label extension study, in which eligible patients from the Phase 3 trials may participate.