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MorphoSys Completes Enrollment in MOR103 Phase 1b/2a RA Trial

Published: Tuesday, August 28, 2012
Last Updated: Tuesday, August 28, 2012
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Study data expected in Q3 2012.

MorphoSys AG has announced the successful completion of patient enrollment in its phase 1b/2a clinical trial evaluating MOR103, a HuCAL antibody targeting GM-CSF (granulocyte macrophage-colony stimulating factor).

96 patients with active rheumatoid arthritis (RA) have been randomized in the double-blind, placebo-controlled study at various clinical centers in Europe to evaluate the safety and preliminary signs of clinical activity of MOR103 when administered intravenously in multiple doses. Data from the trial will become available in Q3 2012.

"Within the past months, MorphoSys's entire proprietary portfolio has advanced significantly," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

Dr. Schottelius continued, "We currently have four proprietary programs in clinical trials, all of them targeting novel or better treatment options for severe diseases. We are well on track to expect a whole range of exciting news from our own development portfolio in the years to come. GM-CSF is strongly implicated in the pathogenesis of inflammatory diseases, including rheumatoid arthritis. Data generated with an antibody targeting the GM-CSF receptor last year provided further clinical validation of the GM-CSF pathway in RA."

In addition to the RA study, MOR103 is currently being evaluated in two additional clinical trials. Patient enrollment in a phase 1b dose-escalation study in multiple sclerosis began in early 2012.

A phase 1 pharmacokinetic study in healthy volunteers to evaluate a subcutaneous formulation of MOR103 will recruit the final cohort shortly.

Subcutaneous injection represents a more convenient route of administration for patients and the data will help guide dosing regimens for future clinical trials for MOR103.

In total, MorphoSys currently has four proprietary clinical programs ongoing, including MOR103 in RA and MS, as well as MOR202, a HuCAL antibody targeting CD38, in multiple myeloma and MOR208, an Fc-enhanced humanized antibody targeting CD19, in chronic lymphocytic leukemia and other B-cell malignancies.


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