Date: 2012-11-06
Type of information: Presentation of results at a congress
phase: 1b-2a
Announcement: presentation of data at the American College for Rheumatology Annual Meeting
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:
Latest
news: MorphoSys has announced that its late-breaking abstract to present data from the phase 1b/2a clinical trial evaluating its proprietary HuCAL antibody MOR103 in rheumatoid arthritis at this year\'s American College for Rheumatology Annual Meeting has been accepted. In addition to the safety and efficacy data published on September 20th, MorphoSys published supplementary data from the phase 1b/2a trial including EULAR response rates, changes in DAS28 scores as well as RAMRIS scores used to analyze MRI imaging in RA trials.
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. MOR103 showed excellent safety data at all doses administered.
With regards to efficacy, the trial was designed to look in particular at the onset of the therapeutic effect. At week four, a significant decrease of the DAS28 score was seen in the MOR103 group with a mean difference of 1.12 and 0.61 in the 1.0 mg/kg and 1.5 mg/kg cohorts respectively, while an increase of 0.17 was documented for placebo.
EULAR response criteria were met in 68.2% of the 1.0 mg/kg dose group and in 69.5% of the 1.5 mg/kg dose group in comparison to 7.4% in the placebo group. The clinical activity was mirrored by a reduction in the RAMRIS score for joint swelling/synovitis of up to -1.5 within 4 weeks.
The data will be presented by the principal investigator of the study, Prof. Harald Burkhardt, Professor of Rheumatology and Head of the Division of Rheumatology at Goethe University Frankfurt in a presentation session on November 13, 2012.
The full abstract is available on http://www.acrannualmeeting.org/
