MorphoSys Reports Filing for Phase 1b/2a Trial for its Lead Program MOR103 in Rheumatoid Arthritis
News Jun 24, 2009
MorphoSys AG has announced that the Company has submitted an application for the authorization of a phase 1b/2a clinical study in patients with active rheumatoid arthritis (RA) for its lead drug MOR103, a fully human HuCAL-derived monoclonal antibody directed against Granulocyte Macrophage-Colony Stimulating Factor.
The trial, which will be conducted in multiple centers in several European countries, is expected to enroll 135 patients in total beginning in the second half of 2009.
Additionally, the Company has reported positive results from the phase 1 clinical study for MOR103 in healthy volunteers. The results of this study indicate that MOR103 is generally safe and well tolerated at all doses administered.
"We are pleased to advance the clinical development of this promising compound into a phase 1b/2a clinical trial to further evaluate safety and tolerability as well as clinical activity in RA patients," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys.
"In combination with the attractive preclinical profile the results we have seen in the phase 1 trial support our plans to develop MOR103 as a safe and efficacious drug for the treatment of inflammatory disorders. In addition to the excellent characteristics the antibody has shown so far with regard to affinity, specificity and stability, we have been able to demonstrate a robust serum half-life in humans," continued Dr. Schottelius.
The completed phase 1 trial was designed as a randomized, double-blind, placebo controlled single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of MOR103 in healthy volunteers.
In total, 63 volunteers received ascending doses of MOR103 up to a concentration of 3 mg/kg or placebo in seven dose cohorts via intravenous infusion. No maximum tolerated dose (MTD) was reached in the study. Analysis of the pharmacokinetic properties of MOR103 showed a serum half-life typical of a fully human antibody which could translate into a competitive dosing regimen.
The overall safety, tolerability and pharmacokinetic properties of MOR103 provide a solid foundation for the Company's development plans, including the forthcoming Phase 1b/2a study in patients.