MorphoSys Receives Regulatory Approval to Start Phase 1b/2a Clinical Trial for MOR103 Program
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MorphoSys AG has announced that it 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 lead drug MOR103, a fully human monoclonal antibody directed against Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF).
In total, the randomized, double-blind, placebo-controlled, dose-escalation trial is expected to enroll 135 patients and will be conducted in multiple centers in several European countries.
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 the first half of 2012.
The primary endpoint of the trial is to determine the safety and tolerability of multiple doses of up to 1.5 mg/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.
"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," commented Dr. Arndt Schottelius, Chief Development Officer. "We'll continue to work towards finalization of the entire approval process in all European countries where we have filed."
In total, the randomized, double-blind, placebo-controlled, dose-escalation trial is expected to enroll 135 patients and will be conducted in multiple centers in several European countries.
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 the first half of 2012.
The primary endpoint of the trial is to determine the safety and tolerability of multiple doses of up to 1.5 mg/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.
"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," commented Dr. Arndt Schottelius, Chief Development Officer. "We'll continue to work towards finalization of the entire approval process in all European countries where we have filed."
