MorphoSys To Initiate Phase 1b/2a Clinical Trial With Rheumatoid Arthritis Patients

MorphoSys has received clearance from Germany’s Paul-Ehrlich-Institute as well as a positive opinion from the ethics committees in Germany to commence a Phase 1b/2a human clinical trial in patients with rheumatoid arthritis (RA) of its drug MOR103. The drug ia a fully human monoclonal antibody directed against Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF).

The randomised, double-blind, placebo-controlled, dose-escalation trial is expected to enroll 135 patients and will be conducted in multiple centers in several European countries.

In the study, the patients with active RA despite previous therapy with NSAIDs, corticosteroids, DMARDs and/or anti-TNF-alpha will each receive four infusions of either the HuCAL-derived antibody MOR103 or placebo in three ascending dose cohorts. Enrollment is expected to be completed in the first half of 2011. The final results of the trial are expected in H1 2012.

The company said that he primary endpoint of the trial is to determine the safety and tolerability of multiple doses of up to 1.5mg/kg of MOR103 in patients with active RA. Secondary outcome measures will evaluate pharmacokinetics, immunogenicity, and the drug’s potential to improve clinical signs and symptoms of RA as measured by ACR and EULAR28 response criteria and patient reported outcomes.

Arndt Schottelius, chief development officer of MorphoSys, said: “We are pleased to have achieved clearance by the regulatory authorities and ethics committees in Germany in such a short time frame which speaks for the high quality of the application documents provided by MorphoSys. We’ll continue to work towards finalisation of the entire approval process in all European countries where we have filed.”