MorphoSys Reports Successful Phase 1 Study of MOR103 Using a Subcutaneous Administration
Results Underline the Compound's Potential to be an Important New Drug for the Treatment of Chronic Inflammatory Diseases
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today 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. 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.
"We are very pleased with these data showing that a subcutaneous administration of our MOR103 antibody is a feasible and attractive option for the future treatment of various inflammatory diseases with this compound," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "In addition to the excellent safety and efficacy data we have presented seven weeks ago, today's news adds another valuable component to the broad commercial and scientific package we are building around our anti GM-CSF program."
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.
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare. The Company's AbD Serotec unit uses HuCAL and other antibody technologies to generate superior monoclonal antibodies for research and diagnostic applications.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 70 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® and Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
For more information, please contact:
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-122
Senior Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-454
Specialist Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-332
Posted: November 2012