Navidea Biopharmaceuticals, Inc. Announces Results of Exploratory Analysis Completed on July 2, 2024

Navidea Biopharmaceuticals, Inc. a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announced disappointing results of an exploratory analysis conducted on the Company’s pivotal NAV3-33 clinical trial titled “Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)” (ClinicalTrials.gov Identifier: NCT05246280) the “RA Trial.”

The purpose of the exploratory analysis was to optimize the diagnostic performance in support of the methodologies to be applied in the final pivotal trial. The results confirm that intravenous Tc 99m tilmanocept can target and produce reliable images of macrophage activity in RA patients, but that these images do not adequately predict which patients will respond to treatment with an anti-TNF alpha medication.

“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%,” said Dr. Michael Blue, Navidea’s Chief Medical Officer. “Results with that predictive value are not indicative of a commercially viable product.”

Given these results, Navidea is suspending all activities related to the RA Trial. The Company is pivoting to focus on exploring all opportunities related to the Company’s therapeutic assets.