Navidea Biopharmaceuticals Announces End-of-Phase 2 Type B Meeting Request Granted by the FDA to Discuss Ongoing Clinical Pro...
July 15 2021 - 7:30AM
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 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”) α 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-TNFα 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-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.”
Jed Latkin, Chief Executive Officer and Chief Financial Officer
for Navidea, said, "We are very excited to meet with the FDA and
finally proceed with launching the Phase 3 trial for the approval
of Navidea’s RA monitoring agent. The clinical and regulatory teams
have been working non-stop to complete the review of a massive
amount of data obtained from NAV3-31. I am extremely proud of the
work they have accomplished to date and eagerly anticipate the next
steps towards approval."
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.
Reference 1.
https://www.rheumatoidarthritis.org/ra/facts-and-statistics/
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
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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
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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
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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
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Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
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