DGAP-News: MorphoSys AG
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02.03.2021 / 22:01
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MorphoSys’s Licensing Partner GSK Shared Preliminary Results From OSCAR Study with Otilimab for the Treatment of Severe Pulmonary COVID-19 Related Disease; Expanding the Study for Patients 70 Years and Older
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that its licensing partner GlaxoSmithKline plc (LSE/NYSE: GSK) reported preliminary results of the OSCAR (Otilimab in Severe COVID-19 Related Disease) study using otilimab (formerly MOR103/GSK3196165) for the treatment of severe pulmonary COVID-19 related disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially significant findings.
This event of the first patient dosed in the expanded study triggers milestone payments of a total of €16 million to MorphoSys.
Otilimab is an investigational human monoclonal antibody directed against GM-CSF (granulocyte-macrophage colony-stimulating factor) that was generated by MorphoSys and outlicensed to GSK in 2013. GSK is also developing otilimab for the treatment of rheumatoid arthritis in the ongoing Phase 3 ContRAst trials.
“The preliminary study results with otilimab are encouraging news for patients 70 and older with severe COVID-19 related pulmonary disease,” said Dr. Malte Peters, Chief Research and Development Officer of MorphoSys AG. “We are pleased that our licensing partner GSK is expanding the study in order to further explore otilimab as a potential treatment option for this group of older adults suffering from severe forms of COVID-19.”
About the OSCAR study
This global, randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept phase 2a OSCAR study (NCT04376684) assessed the efficacy and safety of a single intravenous infusion of otilimab 90 mg given over an hour or placebo in addition to standard of care in 806 hospitalised adults (ages 18 to 79 years) with severe COVID-19 related pulmonary disease. Standard of care permitted the use of corticosteroids (including dexamethasone), remdesivir, and convalescent plasma according to local hospital/institutional policies. Study participants were enrolled at 130 sites around the world, including in the United States, Europe, Asia, Russia, South Africa and South America. All participants had a positive SARS-CoV-2 test result; been hospitalised due to a diagnosis of pneumonia; had new onset of oxygenation impairment requiring high-flow oxygen, non-invasive ventilation or mechanical ventilation <48 hours before dosing; and had increased biological markers of systemic inflammation.
Participants were considered ‘alive and free of respiratory failure’ if they were off significant oxygen support measured using a GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. A full analysis is ongoing and will be made available in an upcoming pre-print publication when available.
Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.
Monjuvi(R) and HuCAL(R) are registered trademarks of MorphoSys AG.
MorphoSys Forward-Looking Statements
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