MorphoSys Initiates Phase 1b Clinical Trial with MOR103 in Patients with MS
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MorphoSys AG has announced that a phase 1b clinical trial evaluating MOR103, a human monoclonal antibody to GM-CSF (granulocyte macrophage-colony stimulating factor), in patients with multiple sclerosis (MS) is now open for enrollment, thereby adding a second indication to the development program.
A phase 1b/2a trial in patients with active rheumatoid arthritis is ongoing and is on track to report data by mid of 2012. Additionally, a phase 1 pharmacokinetic (PK) study in healthy volunteers to evaluate a subcutaneous formulation of MOR103 will commence shortly.
"Our proprietary portfolio has made significant progress this year," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
Dr. Schottelius continued, "These two new studies further increase the value of our lead proprietary drug MOR103. GM-CSF is strongly implicated in the pathogenesis of inflammatory diseases, including rheumatoid arthritis and multiple sclerosis. Recent in vivo data generated in animal models for MS demonstrate that inhibition of GM-CSF improves disease scores, which further substantiates the decision to choose MS as the second indication for MOR103. My team and I are thus very excited that the phase 1b study in multiple sclerosis has been initiated."
The phase 1b dose-escalation study in multiple sclerosis will determine the safety of three doses of MOR103. In total, 30 patients will be enrolled in the study which is planned to be conducted at sites in Germany, the UK and Poland.
The PK study will evaluate the pharmacokinetics, bioavailability, safety and tolerability of subcutaneously administered MOR103 in 32 healthy volunteers.
Subcutaneous injection represents a more convenient way of administration for patients and the data will help guide dosing regimens for future clinical trials for MOR103. Enrollment for this trial is expected to be completed in 2012.