Navidea drops rheumatoid arthritis programme after failed Phase III trial [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
The Phase III study (NCT05246280), which enrolled 523 patients, aimed to confirm the ability of intravenous (IV) Lymphoseek (Tc 99m tilmanocept) imaging to predict clinical response in individuals with RA who are beginning anti-tumour necrosis factor alpha (TNFa) therapy. The exploratory analysis sought to optimise the diagnostic performance in support of the methodologies for a final pivotal trial. While the results confirmed that IV Lymphoseek can reliably image macrophage activity in RA patients, the images cannot predict which patients will respond to treatment with an anti-TNFa medication. On the results of the exploratory analysis, Navidea's CEO Michael Blue said: “We were very surprised and disappointed that the results of the exploratory analysis did not support the hypothesis of an overall accuracy of early treatment response approaching 90%, but rather, the overall accuracy of early treatment response was on average consistently below 70%.” Following these results, Na
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