Navidea Biopharmaceuticals Announces 50th Participant Enrolled in the Company’s Phase 3 Trial in Rheumatoid Arthritis
November 28 2022 - 8:30AM
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 enrollment of the 50th 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.
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Navidea Biopharmaceuticals, Inc. Jeffrey Smith Vice President of
Operations 614-822-2365 jsmith@navidea.com
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