• Successful phase 1 study of antibody MOR103, good news for CID sufferers

Solid Phase Extraction (SPE)

Successful phase 1 study of antibody MOR103, good news for CID sufferers

Nov 26 2012

Subcutaneous administration of HuCAL-based monoclonal antibody MOR103 was accepted, safe and established a positive and competitive pharmacokinetic profile in a clinical phase 1 study in healthy study participants.

MorphoSys AG announced that this competitive pharmacokinetic profile has good bioavailability and a half-life of 17 days, which support subcutaneous administration of this antibody during clinical trials in future.

Also the high neutralizing potency was revealed to be similar to the intravenous administration.

The research will assist in determining dosing schedules for future clinical trials with MOR103 and it was found that subcutaneous injection embodies a more suitable route of administration for patients.

"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 the company.

The expert stated that along with the safe and effective results displayed, the success of this first trial attaches an extra important element to the broad commercial and scientific package it is creating surrounding its anti GM-CSF programme.

Exactly 32 healthy volunteers participated in the phase 1 pharmacokinetic study and consecutively "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".

A phase 1b/2a clinical trial examining the compound, MOR103, in rheumatoid arthritis sufferers has ended.

The safety and efficacy data that was revealed prove MOR103's likelihood to become a "first-in-class treatment modality for [rheumatoid arthritis] patients, with a novel and differentiated mechanism of action".

MOR103 is also presently being tested in a phase 1b dose-escalation study in multiple sclerosis.

MorphoSys produced HuCAL, the most successful antibody library technology in the pharmaceutical trade. By effectively applying this and other patented technologies, the firm has led the industry in therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.

Posted by Ben Evans


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