Benzinga | Dec 15, 2021 04:04PM EST

Navidea Biopharmaceuticals Completes Full Enrollment In Phase 2b Normative Database Study To Support Its Rheumatoid Arthritis Program

Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that it has achieved full enrollment in its NAV3-35 Phase 2b clinical study titled "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept."

Establishing a healthy subject database is necessary to create a quantitative method for determining RA-involved inflammation in joints. The NAV3-35 Phase 2b clinical trial accomplishes this goal. The trial has two arms, with Arm 1 designed to acquire hand and wrist planar (two-dimensional) images from healthy subjects that were age and sex-matched to the RA population and injected with Tc99m tilmanocept. Arm 2 is a pilot feasibility study to examine the potential of three-dimensional SPECT/CT imaging of the hands and wrists of healthy subjects and patients with RA injected with Tc99m tilmanocept. The main objective of the trial is to complete the healthy subject (normative) database in support of the Company's RA imaging commercial product development. A total of 120 healthy volunteers were enrolled in Arm 1. Enrollment is also finalized in Arm 2 of the study.

Tc99m tilmanocept attaches to mannose receptors (CD206) on macrophages that are frequently involved in RA joint inflammation. Relatively smaller numbers of CD206-expressing macrophages normally reside in the joints of healthy people without RA. An integral part of the ability to quantitatively discriminate RA-inflamed joints from those that do not have inflammation using Tc99m tilmanocept imaging is the knowledge of the distribution of Tc99m tilmanocept localization in healthy joints. The establishment of this database will enable improved accuracy of discrimination of RA-involved joints from non-RA inflamed joints and should have a positive impact on the ability to predict treatment response early, the primary indication the Company is pursuing in RA in the upcoming Phase 3 trial.

This database will also be used in the training of automated image analysis software to further improve the accuracy of the quantification of Tc99m tilmanocept localization in joints as well as the workflow for later commercialization in RA.

Dr. Michael Rosol, the Company's Chief Medical Officer, said, "We are pleased to have reached this important milestone in our RA program pipeline. This healthy subject normative database will allow us to define the parameters of what a normal joint looks like with Tc99m tilmanocept, and with that information we can improve upon the quantitative determination of RA-inflamed joints." Dr. Rosol continued, "This database will play an essential part in both the Phase 3 data analysis as well as commercial product. It will not only enable us to more accurately quantitate RA-involved inflammation but, along with the proprietary algorithm we use to read the images, it will serve as an additional barrier to entry for possible long-term competition. This is a critical step forward in the advancement of our RA program into the upcoming Phase 3 trial."