NovImmune SA’s New Rheumatoid Arthritis Drug Clears Regulatory Hurdles

Company to Test First in Class, Personalized Medicine in Patients

GENEVA — Novimmune SA announced today that it received approvals from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency to begin testing a new experimental drug in patients with rheumatoid arthritis, or RA.

Recent estimates by the World Health Organization indicate that up to 73 million people worldwide may be afflicted with RA. Approximately 40% of RA patients fail to respond to current treatments despite receiving conventional and biologic disease modifying anti-rheumatic drugs. In addition, less than 30% of all patients achieve complete disease remission according to the ACR/EULAR Working Committee on RA Remission.

No biomarkers are currently available that can predict treatment response in advance. As a result, patients must endure a trial and error approach to finding the treatment to which they best respond.

“With our new drug, NI-0101, Novimmune hopes to enhance treatment effectiveness through the ability to predict response prior to drug administration,” said Novimmune Chief Executive Officer Jack Barbut. “If the results of the new trial confirm our hypothesis, this approach could lead to NI-0101 becoming the first personalized medicine for RA sufferers and ultimately delivering a higher response rate than current treatments.”

“Due to its differentiated mechanism of action, NI-0101 offers the possibility to tackle RA by interfering with a relevant pathogenetic aspect of the disease that has not been explored to date as a therapeutic target,” said Cristina de Min, chief medical officer at Novimmune. “Our research has identified biomarkers that, when present in RA patients, are believed to indicate a significantly increased likelihood of positive response to the action of our drug.”

NI-0101 is a first in class monoclonal antibody targeting Toll-like receptor 4 (TLR4). Being first in class means it is the first therapeutic antibody in the world directed against this specific target. TLR4 is an important receptor in the body that activates the human innate immune response. Published research has suggested that excessive TLR4 activation may be responsible for the inflammation associated with RA.

About Novimmune SA

Novimmune SA is a Swiss biopharmaceutical company focused on the discovery and development of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer. The company is headquartered in Geneva. More information is available on the company website at

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