Benzinga | Jul 15, 2021 07:34AM EDT

Navidea Biopharmaceuticals Announces End-Of-Phase 2 Type B Meeting Request Granted By FDA To Discuss Ongoing Clinical Program In Rheumatoid Arthritis

Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the U.S. Food and Drug Administration ("FDA") has granted the Company's request for an End-of-Phase 2 Type B meeting to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.

The meeting with the FDA will be centered on discussion of the results from the Company's completed Phase 2b NAV3-31 study, "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" and the proposed protocol and analysis plans for the Phase 3 trial. Previously, the FDA reviewed the interim data and provided pertinent feedback on progressing the remaining patient data and encouraged an End-of-Phase 2 meeting when complete.

Navidea's NAV3-31 trial had three arms: Arm 1 consisted of healthy subjects, Arm 2 was comprised of patients with active, moderate-to-severe RA who are on stable therapy, and Arm 3 was a pilot arm designed to assess the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") ? treatment in RA patients. Previously reported interim analyses demonstrated results in support of Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.

The pivotal Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNF? therapy. The design and planned conduct of the Phase 3 trial is built upon insights and data from the completed Phase 2b NAV3-31 trial.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are eager to discuss the results from our completed Phase 2b trial as well as the design of the planned Phase 3 trial with the FDA. Throughout our RA program development, we have worked closely with expert rheumatologists, nuclear medicine specialists, and the FDA itself, 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-TNF? 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."