NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90)
(the “Company” or “NurExone”), a pioneering biopharmaceutical
company, is pleased to announce the preliminary results from a
small-scale controlled study exploring the use of its flagship
nanodrug, ExoPTEN, for optic nerve recovery in a rat model at Sheba
Medical Center. This study marks a second clinical indication being
investigated for ExoPTEN.
The study was initiated by Professor Michael
Belkin, following the success of ExoPTEN in nerve regeneration in
the spinal cord indication in preclinical models. An Optic Nerve
Crush (“ONC”) model was used to simulate conditions like glaucoma,
where the optic nerve is crushed, resulting in impaired vision.
Glaucoma is a common eye condition, particularly
in older adults typically caused by optic nerve compression and
pressure in the eye. The prevalence of glaucoma in the Western
world is generally estimated to be around 2-3% in people aged 40
and older. The risk increases with age, and the prevalence can be
higher in populations over 60. Estimated Number of People Affected
in the United States alone, is over 3 million people, with many
more cases likely undiagnosed.
The study carried out under Prof. Ygal
Rotenstreich and Dr. Ifat Sher of Sheba Medical Center explored the
therapeutic effects of ExoPTEN on retinal function after ONC
compared to healthy baseline levels, an untreated ONC control and
ONC treated with naïve exosomes. Importantly ExoPTEN was
administered minimally-invasively using suprachoroidal injection in
a delivery system invented by Prof. Rotenstreich.
As expected, the post-ONC control eyes exhibited
a marked decline in retinal functionality, as evidenced by the lack
of a peak (Fig. A – red graph). Experimental treatments with
ExoPTEN (“ONC+PTEN"), showed promising results, with treated eyes
exhibiting a peak similar to the healthy eye in the same animal
indicating recovery of retinal response following optical nerve
compression (Fig. B – green graph). The naïve exosome-treated rats
(“ONC+EXO”) showed a lower peak and increased latency indicating a
weaker response (Fig. C – brown graph). The results presented are
from just 18 days following the ONC damage. These treatment
findings suggest potential pathways for recovery of optic nerve
function and overall healthy vision.
Dr. Ifat Sher and Prof Ygal Rotenstreich of
Sheba Medical Center commented: "While these results are
preliminary, they form a solid foundation for further research. Our
next steps include more extensive studies to validate these
findings and explore their potential application for humans."
Dr. Lior Shaltiel, CEO of NurExone, added: "We
are excited by these preliminary findings and commend the team at
Sheba for this work, which is an important step in our mission to
develop regenerative therapies. These early studies suggest
potential for ExoPTEN in the US$3.4 billion glaucoma market and
will allow us to help those affected by retinal degenerative
conditions."
Figure 1 – Positive
impact of specific treatments on retinal health
Graphs A-C show Electroretinogram (ERG)
measurements of dark-adapted (scotopic) threshold retinal response
(STR, in microvolts, V) at -36 dB of three representative rats. In
each rat, one eye was left intact as a healthy control (“Healthy”,
gray). Rat A had ONC in one eye (red) with no treatment, which
resulted in a flat, near-zero retinal response. Rat B had ONC in
one eye and was treated with ExoPTEN (green, ONC+PTEN), resulting
in a retinal response similar to the healthy intact contralateral
eye. Rat C had ONC in one eye and was treated with naïve exosomes
(brown, ONC+EXO), resulting in a recordable but delayed and smaller
retinal response compared to the healthy control contralateral eye.
The results are following the minimally-invasive administration of
two treatment cycles (one post-operation and the other in the
subsequent week), with a volume of 20μL per eye in the treated and
the control rats (naïve exosomes).
About NurExone Biologic
Inc.
NurExone Biologic Inc. is a TSXV listed
pharmaceutical Company that is developing a platform for
biologically-guided exosome-based therapies to be delivered,
non-invasively, to patients who have suffered Central Nervous
System injuries. The Company’s first product, ExoPTEN for acute
spinal cord injury, was proven to recover motor function in 75% of
laboratory rats when administered intranasally. ExoPTEN has been
granted Orphan Drug Designation by the FDA. The NurExone platform
technology is expected to offer novel solutions to drug companies
interested in noninvasive targeted drug delivery for other
indications.
For additional information, please
visit www.nurexone.com or follow NurExone
on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior ShaltielChief Executive Officer and DirectorPhone:
+972-52-4803034Email: info@nurexone.com
Thesis Capital Inc.Investment Relation - CanadaPhone: +1
905-347-5569Email: IR@nurexone.com
Dr. Eva ReuterInvestment Relation - GermanyPhone:
+49-69-1532-5857Email: e.reuter@dr-reuter.eu
FORWARD-LOOKING
STATEMENTS
This press release contains certain
“forward-looking statements” that reflect the Company’s current
expectations and projections about its future results. Wherever
possible, words such as “may”, “will”, “should”, “could”, “expect”,
“plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or
“potential” or the negative or other variations of these words, or
similar words or phrases, have been used to identify these
forward-looking statements. Forward-looking statements in this
press release include, but are not limited to, statements the scope
and benefits of the stated study, including the proposed subsequent
studies; the statement that the NurExone platform technology is
expected to offer novel solutions to drug companies interested in
noninvasive targeted drug delivery for other indications, including
recovery of optic nerve function and overall visual health; the
website and its benefits; and the Company’s ongoing commitment to
using its ExoTherapy platform and nanodrug ExoPTEN to treat acute
spinal cord injuries.
These statements reflect management’s current
beliefs and are based on information currently available to
management as at the date hereof. In developing the forward-looking
statements in this press release, we have applied several material
assumptions, including the Company’s ability to carry out the scope
and realize upon the benefits of the stated study; the Company’s
ability to realize upon the stated potential for its nanodrug
ExoPTEN to treat acute spinal cord injuries; the Company’s ability
to realize the NurExone platform technology to offer novel
solutions to drug companies interested in noninvasive targeted drug
delivery for other indications.; the new website being more clear,
intuitive, and easy to follow for collaborators, pharmaceutical
companies, and other stakeholders; and the Company’s ability to
maintain its ongoing commitment to using its ExoTherapy platform to
advance the field of regenerative medicine.
Forward-looking statements involve significant
risk, uncertainties and assumptions. Many factors could cause
actual results, performance or achievements to differ materially
from the results discussed or implied in the forward-looking
statements. These risks and uncertainties include, but are not
limited to, risks related to the Company’s inability to carry out
the scope and realize upon the benefits of the stated study; lack
of revenues to date; government regulation; market acceptance for
its products; rapid technological change; dependence on key
personnel; the fact that its nanodrug ExoPTEN is still under
development; the fact that the effects of the nanodrug ExoPTEN are
still uncertain; the potential inability to obtain or maintain
regulatory approval of ExoPTEN; the introduction of competing drugs
that are safer, more effective or less expensive than, or otherwise
superior to, the drug product candidates of the Company; potential
inability to obtain adequate financing; dependence on the Company’s
strategic partners; the protection of the Company’s intellectual
property; the potential inability to obtain or maintain
intellectual property protection for the ExoTherapy platform and
ExoPTEN; risks that the Company’s intellectual property and
technology won’t have the intended impact on the Company and/or its
business; the website not being more clear, intuitive, or easy to
follow for collaborators, pharmaceutical companies, and other
stakeholders; and the risks discussed under the heading “Risk
Factors” on pages 29 to 36 of the Company’s Annual Information Form
dated March 30, 2023, a copy of which is available under the
Company’s SEDAR+ profile at www.sedarplus.ca. These factors should
be considered carefully, and readers should not place undue
reliance on the forward-looking statements. Although the
forward-looking statements contained in this press release are
based upon what management believes to be reasonable assumptions,
the Company cannot assure readers that actual results will be
consistent with these forward-looking statements. These
forward-looking statements are made as of the date of this press
release, and the Company assumes no obligation to update or revise
them to reflect new events or circumstances, except as required by
law.
Neither TSXV nor its Regulation Services
Provider (as that term is defined in the policies of the TSXV)
accepts responsibility for the adequacy or accuracy of this
release.
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