Date: 2012-09-20
Type of information: Results
phase: 1-2a
Announcement: results
Company: Morphosys (Germany)
Product: MOR103
Action
mechanism: MOR103 is a human monoclonal antibody to GM-CSF (granulocyte macrophage-colony stimulating factor).
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: In the randomized, double-blind, placebo-controlled phase 1b/2a trial in 96 mild to moderate RA patients, MOR103 was administered in four weekly doses of 0.3 mg/kg, 1.0 mg/kg or 1.5 mg/kg. The trial, which was designed to look in particular at the onset of the therapeutic effect, was conducted in 26 centers in Germany, Netherlands, Poland, Bulgaria and Ukraine. The majority of the trial participants were on a stable regimen of disease modifying anti-rheumatic drugs. The primary endpoint of the trial was to determine the safety and tolerability of multiple doses of MOR103 in patients with active RA. Secondary outcome measures were pharmacokinetics, immunogenicity, and the drug\'s potential to improve clinical signs and symptoms of RA as measured by DAS28, ACR20/50/70 and EULAR response criteria, MRI imaging for synovitis and bone edema as well as patient reported outcomes.
Latest
news: * On September 20, 2012, MorphoSys has announced results from the phase 1b/2a clinical trial evaluating its proprietary HuCAL antibody MOR103 in rheumatoid arthritis (RA) patients. The positive data make MOR103 the first anti-GM-CSF antibody to demonstrate clinical efficacy in RA. The results demonstrate the compound\'s potential to become an important new drug in an area of unmet medical need. MorphoSys will submit a late-breaking abstract for a forthcoming conference to present the clinical trial results before the end of the year. The best response was achieved in the 1.0 mg/kg dose cohort with an ACR20 score of 68% at week 4, which was significantly higher than in the control arm (p<0.0001). Of particular importance was the fast onset of action observed: within 2 weeks, up to 40% of patients achieved an ACR20 score. Improvement of DAS28 scores was rapid and significant over the treatment period of the study. MRI scans revealed a reduction of synovitis according to the RAMRIS system at week 4. Results at day 28 (Majority of patients were on stable regimen of DMARDS) Placebo MOR103 [0.3 mg/kg] MOR103 [1.0 mg/kg] MOR103 [1.5 mg/kg] Number of patients 27 24 22 23 Proportion of patients achieving ACR20 7% 25% 68% 30% Proportion of patients achieving ACR50 4% 4% 23% 9% MOR103 was safe and well-tolerated at all doses administered. There were no drug-related serious adverse events. No obvious differences in the adverse event rate between the MOR103 and placebo groups were observed. Based on these compelling data, MorphoSys will now proceed with its plans to seek a commercial partner for further development of the program.
In addition to the RA study, MOR103 is currently being evaluated in a phase 1b dose-escalation study in multiple sclerosis. Results of a phase 1 pharmacokinetic study in healthy volunteers to evaluate subcutaneous formulation of MOR103 will be available shortly.
Two research papers underlining the therapeutic potential of antibodies targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) have been recently published.
