NAVB stock exploded 70% higher in after-hours trading on May 21, 2020, after the company reported updated data from its arthritis study.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce positive preliminary results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2B study. Analysis demonstrates that these interim data further corroborate Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (“RA”), and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.

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 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 which 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 weeks on 8 of the 15 subjects. The remaining 7 subjects had received baseline and 5-week scans only 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 demonstrate:

  • Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 7 out of 8 subjects with 12-week clinical assessment available at the time of the interim analysis. The one subject who did not demonstrate concordance of signal quantification and clinical assessment had undergone a change in treatment regime while enrolled in the trial that may have impacted the trajectory of the clinical response.
  • 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.
  • In the subjects with 12-week follow up data available, global Tc99m tilmanocept signals declined by an average of 58% from baseline to week 5 in those who responded significantly to anti-TNF alpha treatment by week 12. In those subjects who did not have a significant clinical response to anti-TNF alpha treatment by week 12, Tc99m tilmanocept signals increased by an average of 79% from baseline to 5 weeks. These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 are in agreement with clinical efficacy evaluations made at week 12 of treatment.
  • 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 interim 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.

Michael Rosol, Chief Medical Officer for Navidea, said, “We are encouraged by these interim results, which are in line with our hypotheses, support the continuation of the current Phase 2B study, and will be fundamental to speaking with the FDA about moving forward into the Phase 3 trial later this year.” Dr. Rosol continued, “We are excited that we are on track to possibly providing rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNF alpha 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 would otherwise be possible today.”

Jed Latkin, Navidea’s Chief Executive Officer, said, “I am once again very pleased that the interim results of our ongoing Phase 2B study are so encouraging. These data support our belief that Tc99m tilmanocept imaging has the potential to provide an early and accurate indication of treatment effectiveness to rheumatologists, allowing them to tailor effective treatment regimens for RA patients. We are looking forward to continuing our progress into a Phase 3 study.”

RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.

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