Date: 2012-11-12
Type of information: Results
phase: 1
Announcement: results
Company: Morphosys (Germany)
Product: MOR103 (antibody targeting granulocyte-macrophage colony-stimulating factor - GM-CSF)
Action
mechanism: MOR103 is a fully human monoclonal antibody directed towards human GM-CSF, a cytokine that leads to activation and proliferation of immune cells causing inflammation. Preclinical studies have shown that MOR103 neutralizes the biological function of human GM-CSF and significantly reduces inflammation by blocking its interaction with cell surface receptors of inflammatory cells, thus inhibiting their activation. These studies suggest that GM-CSF is involved in the pathogenesis of autoimmune diseases such as rheumatoid arthritis and multiple sclerosis.
Disease: chronic inflammatory diseases
Therapeutic area: Autoimmune diseases - Inflammatory diseases
Country:
Trial
details: The phase 1 pharmacokinetic study was conducted in 32 healthy volunteers and sequentially assessed single doses of 0.5, 1.0 and 2 mg/kg MOR103 administered subcutaneously compared to 2 mg/kg MOR103 after single intravenous dosing in cohorts of 8 volunteers.
Latest
news: MorphoSys has announced that subcutaneous administration of its HuCAL-based monoclonal antibody MOR103 was safe and well tolerated and demonstrated a favorable and competitive pharmacokinetic profile in a clinical Phase I study in healthy volunteers. This competitive pharmacokinetic profile is demonstrated by a half-life of 17 days and good bioavailability supporting subcutaneous administration of MOR103 in future clinical trials. Furthermore, the high neutralizing potency was shown to be comparable to the intravenous administration. Subcutaneous injection represents a more convenient route of administration for patients and the data will help guide dosing regimens for future clinical trials with MOR103.
MOR103 has concluded a phase 1b/2a clinical trial evaluating the compound in rheumatoid arthritis. The efficacy and safety data observed underline MOR103\'s potential to become a first-in-class treatment modality for RA patients, with a novel and differentiated mechanism of action. Additionally, MOR103 is currently being evaluated in a phase 1b dose-escalation study in multiple sclerosis.
