16 November 2020 - - Ohio, US-based precision immunodiagnostic agents and immunotherapeutics developer Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has released positive results from analysis of subjects who have completed Arm 3 of the company's ongoing NAV3-31 Phase 2B study, the company said.

These data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active rheumatoid arthritis and that this imaging can provide an early indicator of treatment efficacy.

Navidea's NAV3-31 Phase 2B trial titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value on Tc99m Tilmanocept Planar Imaging" has three arms: Arm 1 consists of healthy subjects, Arm 2 is comprised of patients with active, moderate-to-severe RA who are on stable therapy, and Arm 3 is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor alpha treatment in RA patients.

This third arm was designed in order to evaluate the magnitude of change of Tc99m tilmanocept signal localized to RA-involved joints in patients before and after treatment with an anti-TNF alpha therapy as well as to examine whether the localization or change in localization can serve as an early, quantifiable predictor of treatment efficacy as determined by clinical assessments at 12 and 24 weeks.

A total of 16 subjects with active moderate-to-severe RA were included in this analysis, each of whom was set to begin a new or first-time treatment regimen with an anti-TNF alpha therapy.

Whole body and hand/wrist planar gamma camera images were obtained at baseline prior to initiation of new treatment, again at 5 weeks post therapy initiation, and then again at 12 and 24 weeks.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics.