Navidea discontinued rheumatoid arthritis programme after failed Phase III trial

Navidea Biopharma has dropped its rheumatoid arthritis (RA) program following disappointing results from the NAV3-33 trial's exploratory analysis. The Phase III study (NCT05246280) enrolled 523 patients to assess IV Lymphoseek (Tc 99m tilmanocept) imaging's ability to predict clinical response in RA patients starting anti-tumour necrosis factor alpha (TNFα) therapy.

While Lymphoseek effectively imaged macrophage activity in RA patients, it failed to predict treatment response to anti-TNFα drugs. CEO Michael Blue expressed surprise and disappointment as the early treatment response accuracy consistently fell below 70%, contrary to expectations nearing 90%.

Navidea has consequently suspended all RA trial activities and will focus on exploring opportunities related to its therapeutic assets, as announced in a July 3 press release.

RA involves chronic joint inflammation treated with biologics like Amgen’s Enbrel and Johnson & Johnson’s Remicade, which inhibit TNFα. Lymphoseek, FDA-approved for lymphatic mapping in cancer, identifies sentinel lymph nodes involved in metastasis.