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.
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.