MOR103 at the EULAR 2014 in Paris

MOR10 is an anti-GM-CSF MAB like mavrilimumab, but didn’t show up at the EULAR 2014 Meeting in Paris. I wonder why! Earlier this year there had been a phase 1b/2a study; link: http://www.ncbi.nlm.nih.gov/pubmed/24534756. At the ACR 2012 Meeting in Washington MOR103 showed up with a late breaking poster (Trial Registration Number NCT01023256). Frank Behrens and colleagues presented a poster with the title (Abstract No. L11): “First in Patient Study of Anti-GM-CSF Monoclonal Antibody (MOR103) in Active Rheumatoid Arthritis: Results of a Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Trial”.

Nothing at the EULAR 2013 Meeting in Madrid and nothing at the ACR 2013 Meeting in San Diego. Now nothing again.

So how fits this study in?

F. Behrens and colleagues published in Ann Rheum Dis. 2014, Feb. 17 (doi: 10.1136/annrheumdis-2013-204816) this study: "MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial." Out of the 96 randomised and treated subjects, 85 completed the trial. The objectives were to determine the safety, tolerability and signs of efficacy of MOR103. Conclusions:

"MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA. The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases." It has of course been the study that has been presented almost two years ago (Trial Registration Number NCT01023256).

Maybe I hear the grass grow and maybe it's just that recruiting proves to be difficult, but not showing up at any of the important meetings makes me think. So we have to wait, until "further investigation" has been done.

Good luck for a new mode of action drug, but keep us informed. See you at the next meeting!

MOR103 at the ACR 2012 in Washington

Target GM-CSF, there had been some interesting data, but only published by MorphoSys: http://www.morphosys.com/pressrelease/morphosyss-mor103-antibody-demonstrates-excellent-safety-and-efficacy-rheumatoid-arthritis-patients.

There has been a late breaking poster on MOR103. Frank Behrens and colleagues presented a poster with the title (Abstract No. L11): “First in Patient Study of Anti-GM-CSF Monoclonal Antibody (MOR103) in Active Rheumatoid Arthritis: Results of a Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Trial”. Conclusion: “MOR103 demonstrated rapid and significant clinical activity compared to placebo, most pronounced at the 1.0 mg/kg dosage in this study. Short-term safety and tolerability remained in the range of placebo. …”. So far, so good. But in “results” I’ve found: “Most frequent AEs in the MOR103 group were nasopharyngitis and worsening of RA (in all but one patient in post-treatment follow-up).” We can handle nasopharyngitis, but what does “worsening of RA” stand for? How bad would it be?

MorphoSys seems to be happy with their new child. The German review “Rheuma Management” speaks of promising data. Unless there’s data from a larger study I refrain from taking the same line.