Navidea drops rheumatoid arthritis programme after failed Phase III trial
Rheumatoid arthritis is a chronic progressive disease causing inflammation in the joints and resulting in painful deformity and immobility, especially in the fingers, wrists, feet, and ankles. Navidea Biopharma is dropping its rheumatoid arthritis (RA) programme after announcing disappointing results from an exploratory analysis of the NAV3-33 trial.
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 (TNFα) 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-TNFα medication.
Following these results, Navidea has said it is suspending all activities related to the RA trial. The company will now focus on exploring all opportunities related to its therapeutic assets, as per the 3 July press release.
There are several anti-TNFα drugs approved for use in RA including Amgen’s Enbrel (etanercept) and Johnson & Johnson’s Remicade (infliximab).
Lymphoseek – which is US Food and Drug Administration (FDA)-approved for lymphatic mapping in patients with solid tumours – is a radiopharmaceutical agent designed to identify sentinel lymph nodes that may be involved in metastasis in patients with breast cancer, melanoma, and head and neck cancers.
In 2016, Cardinal Health acquired rights to Lymphoseek from Navidea in North America. Navidea received $80m at closing, plus the opportunity to earn up to $230m based on certain milestones through 2026. In 2021, the diagnostic agent received expanded FDA approval for use in paediatric patients with melanoma, rhabdomyosarcoma (RMS), and other solid tumours.
July 8, 2024
