Navidea Biopharmaceuticals, Inc., a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the launch of the NAV3-33 Phase 3 clinical trial titled “Evaluation of Tc99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA).”

This Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in rheumatoid arthritis (“RA”) patients switching to an anti-TNFα therapy. Trial details will be posted to clinicaltrials.gov.

Rheumatoid Arthritis is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients initiating new RA therapies over a course of three to six months and, in those patients for which the new therapies prove to be ineffective, to change their treatments to an alternative therapy with a different mechanism of action. This trial-and-error process of appropriate treatment selection may take several months to more than a year to arrive at an adequate treatment for any RA patient. Imaging with Tc99m tilmanocept, a synthetic molecule with high affinity to CD206 receptors expressed on activated macrophages, offers the potential to provide an early predictor of clinical response by providing an objective, quantifiable readout of changes in macrophage density in the joints of patients undergoing initiation or change of therapy. These macrophage density changes may be observable weeks before disease modification can be detected with standard clinical assessments.

The data from the Company’s completed NAV3-31 Phase 2b trial demonstrated that Tc99m tilmanocept can provide robust, quantitative imaging in both healthy controls and in patients with active RA, and that this imaging is reproducible and can define joints with and without RA-involved inflammation. The Phase 2b also provided evidence in support of the hypothesis that Tc99m tilmanocept can provide an early prediction of treatment efficacy in patients switching to an anti-TNFα therapy.

The design of the Phase 3 trial is built upon insights and data from this completed Phase 2b study, as well as input from the recent End of Phase 2 Type B meeting with the FDA. The NAV3-33 Phase 3 trial will involve Tc99m tilmanocept imaging in patients with RA who are about to begin an anti-TNFα therapy. Planar (two-dimensional) images of the hands and wrists taken at baseline prior to initiation of therapy and at week 5 following start of therapy will be quantitatively evaluated to assess changes in Tc99m tilmanocept signal localization, if any, in order to predict treatment response or non-response as determined by standard clinical assessments at three and six months post therapy start.

Dr. Michael Rosol, the Company’s Chief Medical Officer, said, “This is a critical milestone in our RA program and for the Company as a whole. Throughout this program’s development, we have worked closely with expert rheumatologists and nuclear medicine specialists, and we believe we are on the right path to bringing a valuable tool to bear to meet a large unmet medical need in patients with RA.” Dr. Rosol continued, “Success would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFα treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is possible today.”