Navidea Biopharmaceuticals Announces Positive Results of First Interim Analysis of Ongoing Phase 2B Study in Rheumatoid Arthritis

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce positive results from the Company’s first interim analysis of its ongoing NAV3-31 Phase 2B study. Analysis demonstrates that these interim data support Navidea’s hypotheses that Tc 99m Tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (“RA”) and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.

Navidea’s NAV3-31 Phase 2B trial titled “Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging” has three arms: Arm 1 consists of healthy subjects, Arm 2 is comprised of patients with active, moderate-to-severe rheumatoid arthritis (RA) who are on stable therapy, and Arm 3 is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc 99m tilmanocept to provide an early indicator of efficacy of anti-TNF alpha treatment in RA patients.

This interim analysis was designed to examine data from Arms 1 and 2 of the study in order to confirm the repeatability, reproducibility, and stability of Tc 99m tilmanocept imaging and further establish the quantitative determinants of healthy joints vs. those with RA-involved inflammation. A total of 30 subjects were included — 18 healthy controls and 12 patients with RA. Whole body and hand/wrist planar gamma camera images were obtained at multiple time points within the same day (both Arms 1 and 2) and on an additional day (Arm 2) to assess imaging stability and variability, which are measures of any change from one image set to the next and from one day to another.

Image sets (whole body and hand/wrist) acquired on the same day at multiple time points demonstrated quantitative repeatability and stability of signal. Importantly, images from patients with active RA show the same localization patterns on images taken a week apart. There was notable agreement between qualitative and quantitative assessment of joint-specific localization across all time points. Data gathered from this interim analysis along with the remainder of NAV3-31 Arms 1 and 2 provide the necessary input to establish quantitative “cut points” to differentiate between joints with and without the inflammation typically seen in RA. These data will also serve to establish the quantitative metrics to enable the detection of change in disease status in patients with RA, in order to determine whether or not a prescribed therapy is having an effect.