MorphoSys Reports Filing for Phase 1b/2a Trial for its Lead Program MOR103 in Rheumatoid Arthritis
News Jun 30, 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 today 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."
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.
Computation and Chemistry Combine to Create World-First Auxetic ProteinNews
A team of chemists at the University of California, San Diego (UCSD) has now designed a two-dimensional protein crystal that toggles between states of varying porosity and density. This is a first in biomolecular design that combined experimental studies with computation done on supercomputers. The research, published in April 2018 in Nature Chemistry, could help create new materials for renewable energy, medicine, water purification, and more.
Fructose Formula Poses Risk to Babies With Metabolic DisorderNews
Babies with inherited intolerance of fructose face a risk of acute liver failure if they are fed certain widely available formulas containing fructose, pediatricians and geneticists are warning. Baby formula manufacturers should remove fructose or sucrose, or explicitly label their products to allow parents to avoid those sweeteners if necessary, the doctors say.
Abzena Selects Sartorius Stedim Biotech to Equip its US Based Development and Manufacturing SitesNews
Abzena plc, the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has selected Sartorius Stedim Biotech as its preferred equipment supplier in the U.S.READ MORE