Novus Therapeutics Doses First Subjects in Phase 1 Pharmacodynamics Study of OP0201

IRVINE, Calif.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24NVUS&src=ctag” target=”_blank”gt;$NVUSlt;/agt;–Novus Therapeutics, Inc. (NASDAQ: NVUS), a specialty pharmaceutical
company focused on developing products for patients with disorders of
the ear, nose, and throat (ENT), today announced that it has dosed the
first adult subjects in study C-001, a phase 1 pharmacodynamics clinical
trial of OP0201, the company’s lead product candidate being developed
for otitis media.

Dr. Catherine Turkel, President of Novus Therapeutics, stated, “In
addition to collecting additional safety information, this study aims to
explore the potential effect of OP0201 on Eustachian tube function as
subjects are exposed to changes in atmospheric pressure. We look forward
to sharing the results from this study later this year.”

Study OP0201-C-001 (“C-001”) is a phase 1 clinical trial designed to
evaluate safety, tolerability, and Eustachian tube (“ET”) function
following a single intranasal dose of OP0201 in 16 healthy adults. The
randomized, double-blind, placebo-controlled, cross-over trial will
explore the effect of a 20 mg dose of OP0201 on ET function. Assessment
of ET function will be captured using continuous tympanic impedance
while subjects are exposed to changes in atmospheric pressure produced
in a hyperbaric/hypobaric chamber. The single center study will be
conducted in Germany. Additional information about the study can be
found at clinicaltrials.gov using the identifier NCT03828149.

About OP0201

OP0201 is being developed as a potential first-in-class treatment option
for otitis media (“OM”), which is often caused by Eustachian tube
dysfunction (“ETD”). OP0201 is a drug-device combination product
comprised of a proprietary formulation of a surfactant
(dipalmitoylphosphatidylcholine or “DPPC”) and a spreading agent
(cholesteryl palmitate or “CP”) suspended in propellant. The product is
administered intranasally via a pressurized metered-dose inhaler
(“pMDI”) and is intended to be used to restore the normal physiologic
activity of the Eustachian tube (“ET”), which is the small tube that
connects the middle ear to the back of the nasopharynx. Together DPPC
and CP are designed to effectively absorb to the air-liquid interface of
the mucosa and reduce the interfacial surface tension of the ET, which
reduces the passive pressure required for the ET to open. In other
words, OP0201 is intended to promote ‘de-sticking’ of the ET so that
ventilation of the middle ear may occur.

About Novus Therapeutics

Novus Therapeutics, Inc. (“Novus”) is a specialty pharmaceutical company
focused on developing products for patients with disorders of the ear,
nose, and throat (“ENT”). Novus has two technologies, each that has the
potential to be developed for multiple ENT indications. Novus’ lead
product candidate (OP0201) is a surfactant-based, drug-device
combination product being developed as a potential first-in-class
treatment option for patients at risk for, or with, otitis media (“OM”
or middle ear inflammation with or without infection). Globally, OM
affects more than 700 million adults and children every year, with over
half of the cases occurring in children under five years of age. OM is
one of the most common disorders seen in pediatric practice, and in the
United States is a leading cause of health care visits and the most
frequent reason children are prescribed antibiotics or undergo surgery.
Novus also has a foam-based drug delivery technology (OP0102), which may
be developed in the future to deliver drugs into the ear, nasal, and
sinus cavities. For more information please visit novustherapeutics.com.

Forward-Looking Statements

This press release contains forward‐looking statements that involve
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Litigation Reform Act of 1995, although not all forward‐looking
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regarding the timing for the commencement and completion of product
development or clinical trials; the rate and degree of market acceptance
and clinical utility of the company’s products; the company’s
commercialization, marketing and manufacturing capabilities and
strategy; the company’s intellectual property position and strategy; the
company’s ability to identify additional products or product candidates
with significant commercial potential; the company’s estimates regarding
expenses, future revenue, capital requirements and needs for additional
financing; developments relating to the company’s competitors and
industry; and the impact of government laws and regulations. Actual
results may differ materially from those indicated by such
forward‐looking statements as a result of various important factors,
including: the ability to develop commercially viable product
formulations; the sufficiency of the company’s cash resources; the
ability to obtain necessary regulatory and ethics approvals to commence
additional clinical trials; whether data from early clinical trials will
be indicative of the data that will be obtained from future clinical
trials; whether the results of clinical trials will warrant submission
for regulatory approval of any investigational product; whether any such
submission will receive approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies and, if we are
able to obtain such approval for an investigational product, whether it
will be successfully distributed and marketed. These risks and
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forward‐looking statements contained herein, are discussed in our
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as well as other filings with the SEC which can be found at www.sec.gov.
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only as of the date hereof and not of any future date, and the company
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Contacts

Investor Contacts

Timothy McCarthy
LifeSci Advisors, LLC
[email protected]
Tel:
(212) 915-2564