Date: 2014-07-28
Type of information: Presentation of results at a congress
phase: 1b
Announcement: presentation of results at ECTRIMS
Company: MorphoSys (Germany)
Product: MOR103
Action
mechanism: MOR103 is a human monoclonal antibody to GM-CSF (granulocyte macrophage-colony stimulating factor).
Disease: multiple sclerosis
Therapeutic area: Neurodegenerative diseases - Autoimmune diseases
Country: Germany, UK, Poland
Trial
details: 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. Data for this trial is expected to be available in 2013. 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.
Latest
news: * On July 28, 2014, MorphoSys provided an update on its proprietary portfolio including the clinical programs MOR208, MOR103 and MOR202. Following the successful completion of the phase 1b trial of MOR103 in multiple sclerosis an abstract covering the results of the phase 1b trial in multiple sclerosis has been accepted for the ACTRIMS-ECTRIMS meeting to take place in Boston in September. Responsibility for further development of MOR103 (GSK3196165) is now fully with GSK. GSK and Morphosys have entered into a global agreement to develop and commercialize MOR103 in June 2013. * On December 21, 2011, MorphoSys AG has announced that a phase 1b clinical trial evaluating MOR103, human monoclonal antibody to GM-CSF (granulocyte macrophage-colony stimulating factor), in patients with multiple sclerosis 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.
