Polyrizon's Moving Forward with Expected 2025 Clinical Trial - Entered Manufacturing Agreement for its PL-14 Allergy Blocker
18 Dezembro 2024 - 8:25AM
Polyrizon Ltd. (the "Company" or "Polyrizon"), a development stage
biotech company specializing in the development of innovative
intranasal hydrogels, previously announced that it entered into a
manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S, a
leading European-based Good Manufacturing Practice (GMP)
manufacturer. This collaboration will supply Clinical Trial
Material (CTM) for Polyrizon’s PL-14 allergy blocker, in
preparation for a clinical trial that is expected to commence in
2025.
With this agreement, which was announced earlier this month,
Polyrizon secures a reliable and compliant manufacturing source for
the PL-14 clinical trial. The trial aims to evaluate the safety and
efficacy of PL-14 as an allergy blocker, advancing Polyrizon's
mission to address allergy-related health issues through unique
nasal sprays.
Tomer Izraeli, CEO of Polyrizon previously stated that “We are
pleased to have established this partnership with Eurofins CDMO
Amatsiaquitaine S.A.S, which strengthens our preparation efforts
for the upcoming PL-14 clinical trial. We believe that this
collaboration marks a significant milestone in our journey toward
providing effective allergy protection solutions to patients."
The manufacturing site is set to support the CTM needs for
Polyrizon's planned 2025 trial, offering high-quality and compliant
development programs in line with USA and European regulatory
standards.
About Polyrizon
Polyrizon is a development stage biotech company specializing in
the development of innovative medical device hydrogels delivered in
the form of nasal sprays, which form a thin hydrogel-based shield
containment barrier in the nasal cavity that can provide a barrier
against viruses and allergens from contacting the nasal epithelial
tissue. Polyrizon’s proprietary Capture and Contain TM, or
C&C, hydrogel technology, comprised of a mixture of naturally
occurring building blocks, is delivered in the form of nasal
sprays, and potentially functions as a “biological mask” with a
thin shield containment barrier in the nasal cavity. Polyrizon are
further developing certain aspects of our C&C hydrogel
technology such as the bioadhesion and prolonged retention at the
nasal deposition site for intranasal delivery of drugs. Polyrizon
refers to its additional technology, which is in an earlier stage
of pre-clinical development, that is focused on nasal delivery of
active pharmaceutical ingredients, or APIs, as Trap and Target ™,
or T&T. For more information, please
visit https://polyrizon-biotech.com.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. The Eurofins Scientific S.E.
network of independent companies believes that it is a global
leader in food, environment, pharmaceutical and cosmetic product
testing and in discovery pharmacology, forensics, advanced material
sciences and agroscience contract research services. It is also one
of the market leaders in certain testing and laboratory services
for genomics, and in the support of clinical studies, as well as in
biopharma contract development and manufacturing. It also has a
rapidly developing presence in highly specialised and molecular
clinical diagnostic testing and in-vitro diagnostic products.
With ca. 62,000 staff across a network of more than 900
laboratories in over 1,000 companies in 62 countries, Eurofins
offers a portfolio of over 200,000 analytical methods. Eurofins
Scientific S.E. shares are listed on Euronext Paris Stock
Exchange.
About Eurofins CDMO
As a prominent Contract Development & Manufacturing
Organization (CDMO), Eurofins CDMO offers a powerful network of
companies across Europe, North America and India that provide
comprehensive, end-to-end solutions for preclinical and clinical
outsourcing services. Eurofins CDMO is specialized in both Drug
Substance / API and Drug Product development for Biologics and
Small Molecules, helping (bio)pharmaceutical companies swiftly
progress from the research phase to the clinical stages.
Forward Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
and other securities laws. Words such as “expects,” “anticipates,”
“intends,” “plans,” “believes,” “seeks,” “estimates” and similar
expressions or variations of such words are intended to identify
forward-looking statements. For example, the Company is using
forward-looking statements when it discusses the timing of the
commencement of its clinical trial and its belief that the
collaboration marks a significant milestone in its journey toward
providing effective allergy protection solutions to patients.
Forward-looking statements are not historical facts, and are based
upon management’s current expectations, beliefs and projections,
many of which, by their nature, are inherently uncertain. Such
expectations, beliefs and projections are expressed in good faith.
However, there can be no assurance that management’s expectations,
beliefs and projections will be achieved, and actual results may
differ materially from what is expressed in or indicated by the
forward-looking statements. Forward-looking statements are subject
to risks and uncertainties that could cause actual performance or
results to differ materially from those expressed in the
forward-looking statements. For a more detailed description of the
risks and uncertainties affecting the Company, reference is made to
the Company’s reports filed from time to time with the Securities
and Exchange Commission (“SEC”), including, but not limited to, the
risks detailed in the Company’s prospectus (Registration No.
333-266745), dated October 24, 2024 and filed with the SEC.
Forward-looking statements speak only as of the date the statements
are made. The Company assumes no obligation to update
forward-looking statements to reflect actual results, subsequent
events or circumstances, changes in assumptions or changes in other
factors affecting forward-looking information except to the extent
required by applicable securities laws. If the Company does update
one or more forward-looking statements, no inference should be
drawn that the Company will make additional updates with respect
thereto or with respect to other forward-looking statements.
References and links to websites have been provided as a
convenience, and the information contained on such websites is not
incorporated by reference into this press release. Polyrizon is not
responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations
IR@polyrizon-biotech.com
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