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Navidea enrolls 50th participant in Phase 3 trial in Rheumatoid Arthritis
The Fly

Navidea enrolls 50th participant in Phase 3 trial in Rheumatoid Arthritis

Navidea Biopharmaceuticals announced enrollment of the 50th participant in the Company’s pivotal NAV3-33 Phase 3 clinical trial titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis" This Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in rheumatoid arthritis patients switching to an anti-TNFa therapy, addressing a large unmet medical need. Overall trial size will range from 198-672 patients, with enrollment targeted to achieve a minimum of 100 clinical responders to anti-TNFa therapy and 98 non-responders. Rheumatoid arthritis is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients starting new RA therapies over a course of three to six months and, in those patients for which the new therapies prove to be ineffective, to change their treatments to an alternative therapy. This trial-and-error process of appropriate treatment selection may take several months to more than a year to arrive at an adequate treatment for any RA patient. Imaging with Tc99m tilmanocept, a synthetic molecule with high affinity to CD206 receptors expressed on activated macrophages, offers the potential to provide an early predictor of clinical response by providing an objective, quantifiable readout of changes in macrophage density in the joints of patients undergoing initiation or change of therapy. These macrophage density changes may be observable weeks before disease modification can be detected with standard clinical assessments. Additionally, in patients with a low-macrophage type of RA who have been shown to be less responsive to anti-TNFa therapy, an initial baseline scan alone could point their physicians to another therapy type that has a better chance of success than an anti-TNFa.

Published first on TheFly

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