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 American College of Rheumatology (“ACR”) has accepted the results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting (“ACR Convergence 2020”) under the title, “Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy.”
This year’s annual meeting will be conducted as a virtual conference from November 5-9, 2020. Navidea’s abstract is accessible online at acrabstracts.org, abstract number 1544, with presentation of the poster on Monday, November 9, 2020 from 9:00 am – 11:00 am Eastern. The poster abstract will also be published in an online supplement of the journal Arthritis & Rheumatology.
Navidea’s NAV3-31 Phase 2b trial titled “Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) 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 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 Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor (“TNF”) alpha treatment in RA patients.
This second interim analysis was designed to examine data from Arm 3 of the study 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 this change in localization, if any, can serve as an early, quantifiable predictor of treatment efficacy.
A total of 15 subjects with active moderate-to-severe RA were included in this interim analysis, each of whom were 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 weeks on 11 of the 15 subjects at the time of this analysis. A panel of established clinical assessments was performed at each time point as well, in order to compare imaging results with clinical standards over the 12-week time course. Results of the preliminary analysis demonstrated:
- Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 9 out of 11 subjects with 12-week clinical assessment available at the time of the interim analysis.
- Combined data from all 15 subjects in Arm 3 suggest a wide dynamic range of more than one order of magnitude (>10-fold) for calculated global Tc99m tilmanocept uptake values in joints with RA-involved inflammation.
- The wide dynamic range of global Tc99m tilmanocept signal readout combined with the low variability of imaging signal quantification established in Arms 1 and 2 of this trial are supportive of the idea that clinically meaningful changes in signal localization can be detected.
- These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 presage clinical efficacy evaluations at week 12 of treatment.
These data are supportive of Navidea’s hypotheses that Tc99m tilmanocept imaging can provide quantifiable imaging assessment of RA-involved joints that enables early prediction of clinical response as well as longitudinal monitoring of clinical status.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted by the recognition of the importance of our Phase 2b interim results by the ACR Convergence 2020 scientific committee and the opportunity to present our results at this internationally recognized meeting.” Dr. Rosol continued, “This is the type of external validation of our work that reflects the great medical need for a robust, objective, noninvasive means of assessing inflammation in RA-involved joints. It is our expectation that Tc99m tilmanocept can address this need and provide critical information for rheumatologists to put their patients on the correct therapeutic pathway earlier than is currently possible.”
Jed Latkin, Navidea’s Chief Executive Officer, said, “It’s a great honor that our clinical trial results in RA have been regularly accepted for presentation at international meetings the last several years, and this acceptance by ACR continues that record of success.”
RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population1. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.