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

IRVINE, Calif.–(BUSINESS WIRE)–lt;a href=”” 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 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

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Investor Contacts

Timothy McCarthy
LifeSci Advisors, LLC
(212) 915-2564

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