Navidea Biopharmaceuticals Announces 50th Participant Enrolled in the Company’s Phase 3 Trial in Rheumatoid Arthritis

Rhea-AI Summary

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced the enrollment of the 50th participant in its pivotal NAV3-33 Phase 3 clinical trial, which aims to evaluate Tc99m tilmanocept imaging for predicting treatment responses in rheumatoid arthritis patients starting anti-TNFα therapy. The trial will involve 198-672 patients, targeting at least 100 responders. Previous Phase 2B data indicated a 90% accuracy in early treatment response prediction at 12 weeks. Success could significantly benefit RA patients and enhance shareholder value.

Positive

• Enrollment of the 50th participant in the NAV3-33 Phase 3 trial.
• Targeting a total of 198-672 patients for robust data collection.
• Previous Phase 2B trial showed 90% accuracy in predicting treatment response.

Negative

• Uncertainty exists regarding the trial's outcome and its potential market impact.
• Long timeline for treatment selection may remain, even with potential advancements.

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced enrollment of the 50^th participant in the Company’s pivotal NAV3-33 Phase 3 clinical trial titled “Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)” (ClinicalTrials.gov Identifier: NCT05246280).

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, addressing a large unmet medical need. Overall trial size will range from 198-672 patients, with enrollment targeted to achieve a minimum of 100 clinical responders to anti-TNFα therapy and 98 non-responders.

Rheumatoid arthritis is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients starting 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. 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. Additionally, in patients with a low-macrophage type of RA who have been shown to be less responsive to anti-TNFα therapy, an initial baseline scan alone could point their physicians to another therapy type that has a better chance of success than an anti-TNFα.

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 trial 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, with an overall accuracy of early treatment response prediction of 90% at 12-week follow up and 86% at 24 weeks.

The design of the Phase 3 trial is built upon data from this completed Phase 2B study, as well as input from the End of Phase 2 Type B meeting with the FDA. The NAV3-33 Phase 3 trial involves Tc99m tilmanocept imaging in participants with RA who are about to begin anti-TNFα therapy. Planar (two-dimensional) images of the hands and wrists are taken at baseline prior to initiation of therapy and at week 5 following start of therapy. These images are 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, Chief Medical Officer for Navidea, said, “This is an important milestone in our RA program and for the Company as a whole. Throughout this program’s development, we have worked closely with expert rheumatologists, nuclear medicine specialists, and the FDA, and we are confident we are on the right path to bringing a valuable tool forward 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 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. We continue to be excited about the level of progress we are making with this trial, the benefits that it could provide to those suffering from RA, and the value a successfully completed trial would create for our shareholders.”

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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Navidea Biopharmaceuticals, Inc.

Jeffrey Smith

Vice President of Operations

614-822-2365

jsmith@navidea.com

Source: Navidea Biopharmaceuticals, Inc.

FAQ

What is the purpose of the NAV3-33 Phase 3 clinical trial by NAVB?

The NAV3-33 trial aims to evaluate Tc99m tilmanocept imaging as an early predictor of treatment response in rheumatoid arthritis patients starting anti-TNFα therapy.

How many participants are expected in the NAV3-33 clinical trial?

The trial is designed to enroll between 198 and 672 participants.

What were the results of the previous NAV3-31 Phase 2B trial?

The NAV3-31 trial demonstrated that Tc99m tilmanocept can predict treatment efficacy with 90% accuracy at 12 weeks.

What potential benefits does Tc99m tilmanocept offer for rheumatoid arthritis treatment?

It may provide an early, non-invasive indication of whether an anti-TNFα treatment is effective, allowing for quicker treatment adjustments.

What is the current stage of the NAV3-33 trial as of the latest press release?

As of the latest release, the trial has successfully enrolled its 50th participant.