MorphoSys has announced positive results from a Phase Ib/IIa trial evaluating HuCAL antibody MOR103 in rheumatoid arthritis (RA) patients.
In the randomised, double-blind, placebo-controlled trial, MOR103 antibody demonstrated positive safety and efficacy in RA patients.
Go deeper with GlobalData
MorphoSys chief development officer Dr Arndt Schottelius said the efficacy and safety data emphasises MOR103’s potential to become a first-in-class treatment modality for RA patients, with a differentiated mechanism of action.
"The quality of the data demonstrates the capabilities of our discovery and development organization and mark a significant step in MorphoSys’s strategy to bring innovative drugs to patients," Schottelius said.
At 1.0mg/kg dose cohort, an ACR20 score was observed among 68% patients at the fourth week, which was significantly higher than in the control arm (p < 0.0001), while up to 40% of patients achieved an ACR20 score within two weeks.
The study observed significant improvement of DAS28 scores over the treatment period, and MRI scans revealed a reduction of synovitis at week four.
According to the study data, MOR103 was safe and well-tolerated at all doses with no drug-related serious adverse events.
Frankfurt University rheumatology division head and rheumatology professor Harald Burkhardt said; "Considering the short first-in-patient study, MOR103 demonstrated very promising clinical activity and fast onset of action with favorable safety data."
Besides the RA study, MOR103 is presently being evaluated in a Phase Ib dose-escalation study for multiple sclerosis.
